The EMA will award a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative which was founded by the African Union Development Agency (AUDA-NEPAD). The move will help to fund a pilot to test procedures for the joint continental evaluation of medicines in Africa. AUDA-NEPAD has been working on harmonisation activities for a decade.

The launch of the African pilot aims to validate procedures and processes ahead of the establishment of the AMA. The pilot, which is co-funded with the Bill & Melinda Gates Foundation, will run for a year.

Under the new initiative, the AMRH Evaluation of Medicinal Products Technical Committee (EMP-TC) will evaluate the quality, safety and efficacy of priority medicinal products with the support of the continental Good Manufacturing Practices Technical Committee (GMP-TC). This will help to develop continental processes and procedures, facilitate national authorisations of recommended medicines and strengthen information sharing and reliance.

The two AMRH technical committees visited EMA in June 2024 to share knowledge and get insights into EMA’s regulatory procedures and processes, which could serve as a model for the African regulatory system.

This pilot is part of EMA’s regulatory support for medical devices, following the introduction of new legislation in the EU in 2022. The plan could bring new products to people with rare diseases and conditions with unmet need.

Orphan devices are medical devices which are intended to be used for diseases or conditions affecting only a small number of individuals each year (fewer than 12,000 individuals in the EU per year). Often they are used to treat or diagnose rare diseases or conditions for which no or insufficient alternative diagnostic or therapeutic options exist, thereby fulfilling an unmet medical need.

The programme will initially benefit selected manufacturers and notified bodies – the national authorities responsible for assessing devices and awarding the CE mark. While the first phase of the programme is currently scheduled to run until the end of 2025, the Agency said it aims to establish a long-term process for orphan device support.

Manufacturers can consult the expert panels at different stages of the development of the clinical strategy for their device, while notified bodies can request advice at specific moments of the ongoing conformity assessment of the device.

As part of the pilot programme, EMA will prioritise certain types of orphan medical devices, such as devices for treating a medical condition that is life-threatening or that could cause permanent impairment of a body function, devices intended for children, and novel devices with potential major clinical benefit.

In June 2024, the European Commission announced new guidance on the clinical evaluation of orphan medical devices issued by the Medical Device Coordination Group, which is composed of representatives of all EU Member States. This guidance sets out criteria to determine when a medical device should be regarded as an orphan device under the EU Medical Devices Regulation and aims to guide manufacturers and national authorities.

Newly-approved products:

• Anzupgo (delgocitinib), a medicine intended for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.
• Iqirvo (elafibranor), for the treatment of primary biliary cholangitis, a chronic and progressive autoimmune disease that can cause liver damage.
• Kayfanda (odevixibat), for the treatment of cholestatic pruritus in patients with Alagille syndrome, a rare, life-threatening genetic disorder with a wide variety of clinical manifestations affecting the liver, heart, skeleton, eyes, skin, central nervous system, kidneys, and facial features.
• Loqtorzi (toripalimab), for the treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.
• Vevizye (ciclosporin), for the treatment of adult patients with moderate to severe dry eye disease which has not improved despite treatment with tear substitutes.
• Vyloy (zolbetuximab), to treat gastric or gastro-oesophageal junction adenocarcinoma, a cancer of the stomach.
• Yuvanci (macitentan / tadalafil), for the treatment of pulmonary arterial hypertension, a chronic and progressive disease of the small pulmonary arteries that is characterised by vascular proliferation and remodelling.

The Committee adopted positive opinions for six biosimilar medicines:

• Eksunbi (ustekinumab) and Fymskina (ustekinumab), for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.
• Ituxredi (rituximab), for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris.
• Otulfi (ustekinumab), for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.
• Ranibizumab Midas (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.
• Tuznue (trastuzumab), for the treatment of breast and gastric cancer.

Marketing authorisation was also approved for Axitinib Accord (axitinib), a generic medicine for the treatment of adult patients with advanced renal cell carcinoma.

Extensions of indication were recommended for eleven products that are already available in the EU for the treatment of other conditions: Arexvy, Braftovi, Edurant, Keytruda, Mektovi, Opsumit, Padcev, Rybrevant, Slenyto, Spevigo and Tecentriq.

In addition, the CHMP finalised its assessment of an application to extend the use of the weight loss medicine Wegovy (semaglutide) to include prevention of major cardiovascular problems in adults with established cardiovascular disease and a body mass index (BMI) of at least 27 kg/m2.

The CHMP considered that this use is already covered by the approved indication for weight management and therefore did not agree to add a separate indication for the prevention of cardiovascular disease. Instead, it recommended to include additional information from a study in the product information.

Only half (53%) of online advertisements for medicines are correctly categorised as legitimate or illicit by Italian and Spanish consumers, posing a significant risk of purchasing substandard and falsified medicines (SFMs).

The illicit market for medicines has grown since the COVID-19 pandemic, exploiting vulnerable consumers through misleading online advertisements and websites. Existing efforts to combat the spread of SFMs online focus mainly on targeting online supply. The CAPSULE project instead focused on the demand side of the market, assessing the exposure and behaviour of consumers.

In January 2024, a survey was conducted among a representative sample of Internet users in Italy and Spain who were aware of the possibility of buying medicines online and had been exposed to online advertising or had bought at least one medicine online. The survey exposed them to a mix of legitimate and illegitimate online advertisements for medicines.

The results showed that consumers correctly categorised legitimate advertisements 63% of the time, but struggled significantly with illicit ads, correctly identifying them only 43% of the time in Italy and 42% in Spain. The most important factors influencing the decisions of the respondents are the absence of a label certifying authorisation by the Ministry of Health, followed by the absence of a drug description or the presence of errors.

The results of the study highlight the need for awareness campaigns tailored to different demographics and types of consumers: while older participants showed less capacity to detect illicit advertisements, younger participants expressed less trust in healthcare professionals and a higher propensity to rely on the Internet for obtaining healthcare information.

Most respondents were aware that legitimate online medicine sales in Italy and Spain are restricted to non-prescription medicines (73% in Italy and 66% in Spain). Only one third distinguished dietary supplements from medicinal products, underscoring the difficulty in distinguishing between products subject to different regulations.

Italian participants exhibited a higher rate of online purchases (69%) of medicines compared to Spain (52%). A substantial majority of Italians (85%) and Spaniards (75%) reported having seen at least one form of online advertisement for medicines.

In Italy, flu treatments were the most popular online purchases, followed by chronic pain and cholesterol management medicines. Spanish consumers mainly bought performance-enhancing and weight-loss products.

‘Given the overall increase in online purchases of medicines, the results highlight the need for better crime-proofing of legitimate advertising and selling channels to reduce the diffusion of substandard or fake medicines,’ said Dr Marco Dugato, researcher at Transcrime,  ‘This also requires a constant support from research in this area to monitor evolving consumer behaviour and market dynamics”.

A global spike in temperatures has increased the likelihood of frequent and intense heatwaves. Previous research on the impact of these changes has revealed that extreme heat disproportionately affects vulnerable groups such as children, the elderly, individuals with chronic health conditions, and those in the low-income group. Despite these observations, however, there are limited studies on the impact of high temperatures on the health of people with disabilities.

To better understand the impact of extreme heat on public health, especially on vulnerable population like people with disabilities, the researchers examined the association between heat and patient admissions in the emergency department. Their study, published in the journal The Lancet Planetary Health, reveals disparities in admissions and medical expenses for individuals with disabilities and those without disabilities.

The researchers examined the health records of 59,527 beneficiaries with disabilities and 1,060,797 beneficiaries without disabilities from the Korean National Health Insurance Service–National Sample Cohort database. They examined the link between short-term exposure to hot temperatures and admissions to the emergency department (ED) in hospitals during warm seasons (June to September) between January 1, 2002, to December 31, 2019.

The study covered four types of disabilities — physical, brain lesion disorders, vision, and hearing impairments — and examined hospitalisations for cardiovascular, genitourinary, mental, and respiratory diseases.

The findings revealed that exposure to heat increased the risk of hospitalisations among individuals with disabilities, especially due to the occurrence of mental and respiratory diseases. In addition, individuals with brain lesion disorders and severe physical disabilities, females, and those older than 65 years were more vulnerable to the effects of heat exposure.

Overall, these results suggest that people with disabilities faced a 1.07 times higher risk, with a four-fold increase in ED admissions and seven times higher medical costs, compared to those without disabilities.

The number of people with disabilities is expected to rise with increases in population ageing and non-communicable diseases. In this context, the findings of this study highlight the need for well-informed public health policies to support and address the specific needs of this group, the scientists said.

‘There are still a limited number of guidelines against climate change in the context of people with disabilities,’ Dr Whanhee Lee, Pusan National University. ‘Our study sheds light on the importance of considering population with disabilities while developing guidelines against climate change.

Cervical cancer screening is essential for early detection and prevention. Most countries have a very extensive screening program that starts with testing for different variants of the human papillomavirus (HPV) that causes cervical cancer. In the case of an HPV-positive test, this is followed by so-called cytological analysis, the examination of gynaecological cell samples by microscopy, which is dependent on human interpretation.

The new molecular test WID-qCIN, which could replace the cytological analysis, can automatically analyse epigenetic changes in cells – changes that affect which genes are active and which are not. These changes are influenced by factors such as environment, lifestyle, and aging, and can increase the risk of cancer and other diseases.

The study included more than 28,000 women over the age of 30 who underwent screening in Stockholm between January and March 2017. The researchers analysed a total of 2,377 HPV-positive samples with the WID-qCIN test combined with a test for two high-risk HPV types (HPV 16 and 18). In this way, they were able to detect 100 per cent of all invasive cervical cancer and 93 per cent of all serious precancerous lesions that occurred within a year of sampling.

In addition, the new test, in combination with the HPV 16/18 test, was able to predict 69 per cent of all cancers and precancerous lesions up to six years after the sample was taken. This can be compared with only 18 per cent with today’s screening method.

‘By integrating the WID-qCIN test into our screening programmes, we would be able to identify more cancer cases while reducing the need for invasive procedures,’ says Prof Joakim Dillner, Karolinska Institutet and co-author of the study.

When cell changes are detected in today’s screening programme, the woman undergoes a vaginal examination, a so-called colposcopy, where the gynaecologist looks at the cervix with the help of a microscope and, if necessary, takes a biopsy. The study suggests that implementation of the WID-qCIN test could reduce the number of colposcopy examinations by 40 per cent.

‘This would mean a significant improvement compared to today’s screening methods, which were introduced in the 1960s,’ says Prof Martin Widschwendter, University of Innsbruck and visiting Professor at the Karolinska Institutet. ‘With its simplicity and objective assessment, the WID-qCIN test can improve the effectiveness of these programs and support the global strategy to eliminate cervical cancer.’

The committee recommended authorisation for the following:

Balversa (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system.

Eurneffy (epinephrine), the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection.

mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine) for prevention in adults 60 years of age and older of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults. This is the first mRNA vaccine targeting a different pathogen than SARS-CoV-2 that receives a positive opinion from the CHMP.

Ordspono (odronextamab) received a conditional recommendation for the treatment of follicular lymphoma and diffuse large B-cell lymphoma, two types of blood cancer that affect the immune system.

Piasky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria, a rare genetic disorder that causes the premature breakdown of red blood cells by the immune system and is potentially life-threatening.

Tauvid (flortaucipir (¹⁸F)) for positron emission tomography (PET) imaging of the brain in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.

Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension, a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs.

Steqeyma (ustekinumab), a biosimilar medicine for the treatment of adult patients with moderate/severe active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis.

The committee also adopted positive opinions for two generic medicines: Enzalutamide Viatris (enzalutamide) for the treatment of prostate cancer, and Nilotinib Accord (nilotinib) for the treatment of Philadelphia chromosome positive chronic myelogenous leukaemia.

Extensions of indication were recommended for 11 medicines that are already authorised in the EU: Betmiga, Beyfortus, Cresemba, Imcivree, Imfinzi, Infanrix hexa, Lynparza, Pegasys, Tepkinly, Vabysmo and Xalkori.

Based on data from the World Health Organization (WHO), the European Medicines Agency (EMA) selected the three most common strains of flu – a break from previous years in which four strains were targeted.

Influenza viruses continuously change and evolve. The periodic replacement of the virus strains contained in influenza vaccines is necessary to keep the vaccines effective. Every year, EMA issues recommendations for the composition of seasonal influenza vaccines based on trends seen last winter and monitoring data from the southern hemisphere flu season.

For 2024/2025, the Agency is recommending a transition from quadrivalent (four-strain) to trivalent (three-strain) vaccines that do not include the B/Yamagata component which was included last year. The B/Yamagata strain of the influenza B virus has not been detected in circulation since March 2020. This is thought to be due in part to the public health measures put in place to limit the spread of COVID-19 during the pandemic. Influenza B viruses are responsible for a quarter of annual influenza infections.

Manufacturers of live-attenuated vaccines, or egg-based trivalent vaccines should include these three virus strains for the 2024/2025 season:

• an A/Victoria/4897/2022 (H1N1)pdm09-like virus;
• an A/Thailand/8/2022 (H3N2)-like virus;
• a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

Manufacturers of cell-based trivalent vaccines should include these three virus strains for the 2024/2025 season:

• an A/Wisconsin/67/2022 (H1N1)pdm09-like virus;
• an A/Massachusetts/18/2022 (H3N2)-like virus;
• a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

The EMA said manufacturers of inactivated vaccines can consider producing a quadrivalent vaccine containing two influenza B virus strains for the 2024/2025 season. ‘In that case a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus in addition to the strains mentioned above is considered appropriate,’ the Agency said in a statement.

The CHMP backed the granting of marketing authorisation for:

Awiqli (insulin icodec) for the treatment of diabetes mellitus in adults.

Emblaveo (aztreonam-avibactam), an antibiotic indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) that are resistant to many currently available antibiotics and where patients have limited or sometimes no treatment options.

Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria, a rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells by the immune system.

Lytenava (bevacizumab), for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease which causes gradual vision impairment mainly in the elderly.

Jubbonti (denosumab), for the treatment of osteoporosis and bone loss.

Omlyclo (omalizumab), for the treatment of asthma, severe chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.

Wyost (denosumab), for the prevention of skeletal related events with advanced malignancies.

Agilus (dantrolene sodium, hemiheptahydrate), for the treatment of malignant hyperthermia, a life-threatening emergency condition in which the skeletal muscles of the body are over-stimulated and are unable to relax.

Neoatricon (dopamine hydrochloride), for the treatment of hypotension in neonates, infants and children.

Three generic medicines also received a positive opinion from the committee: Dimethyl fumarate Accord (dimethyl fumarate), Dimethyl fumarate Mylan (dimethyl fumarate) and Dimethyl fumarate Neuraxpharm (dimethyl fumarate). All three medicines are indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves.

The committee also recommended extensions of indication for six medicines that are already authorised in the European Union (EU): Bimzelx, Nilemdo, Nustendi, Onivyde pegylated liposomal*, Retsevmo and Xtandi.

Influenza viruses continuously change and evolve. That is why it is necessary to review the virus strains contained in influenza vaccines and, if necessary, update them before the new flu season.

Every year, the European Medicines Agency (EMA) issues recommendations for the composition of seasonal influenza vaccines well in advance of flu season, giving manufacturers time to begin production. Some years, there is not change; other years, one or two of the strains are replaced.

The regulator advises companies which strains of flu viruses they should protect against when formulating the revamped vaccine. This is based on WHO data which draws on the experience of the southern hemisphere, where flu season is just beginning.

Based on this data, the EMA’s Emergency Task Force recommends moving from a four-strain vaccine to a three-strain vaccine which does not include the B/Yamagata component featured in recent years. This is because that flu virus has not been very common recent flu seasons, north or south.

In fact, it has not been detected since March 2020, when COVID-19 was declared a global pandemic. This is thought to be due in part to the public health measures put in place to limit the spread of COVID. Influenza B viruses are responsible for a quarter of annual influenza infections.

Given that the B-Yamagata virus strain no longer seems to pose a threat to public health, it is not necessary to include it in the formulation of influenza vaccines, the EMA said.

The ETF recommends that this strain should ideally be removed from all live-attenuated vaccines from the 2024/2025 season. In the interest of guaranteeing vaccine supplies for the coming vaccination campaign, the transition to a trivalent composition for all other influenza vaccines should be completed for the 2025/2026 season.

On foot of this, the following strains are now the priority for the 2024/2025 season.

Manufacturers of live-attenuated vaccines, or egg-based trivalent vaccines should include:

• an A/Victoria/4897/2022 (H1N1)pdm09-like virus;
• an A/Thailand/8/2022 (H3N2)-like virus;
• a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

Manufacturers of cell-based trivalent vaccines should include:

• an A/Wisconsin/67/2022 (H1N1)pdm09-like virus;
• an A/Massachusetts/18/2022 (H3N2)-like virus;
• a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.

Scientists at the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine) and Nestlé Research in Switzerland led an international collaboration which included contributions from the University of Southampton, University of Melbourne, University of Tehran, University of South Alabama, University of Toyama and University of Copenhagen.

The work, published in Nature Metabolism, builds on a previous collaborative study that described novel mechanisms of human sarcopenia. Sarcopenia is a condition where cellular changes that happen during ageing gradually weaken the muscles in the body and lead to accelerated loss of muscle mass, strength and reduced physical independence.

One important problem during sarcopenia is that the cellular cofactor NAD⁺ declines during ageing, while mitochondria, the energy powerhouses in our cells, produce less energy. The study team discovered that levels of trigonelline were lower in older people with sarcopenia. Providing this molecule in pre-clinical models resulted in increased levels of NAD⁺, increased mitochondrial activity and contributed to the maintenance of muscle function during ageing.

NAD⁺ levels can be enhanced with different dietary precursors like the essential amino acid L-tryptophan (L-Trp), and vitamin B3 forms such as nicotinic acid (NA), nicotinamide (NAM), nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN).

Assistant Professor Vincenzo Sorrentino from the Healthy Longevity Translational Research Programme at NUS Medicine said: ‘Our findings expand the current understanding of NAD⁺ metabolism with the discovery of trigonelline as a novel NAD⁺ precursor and increase the potential of establishing interventions with NAD⁺-producing vitamins for both healthy longevity and age-associated diseases applications.’

Nutrition and physical activity are important lifestyle recommendations to maintain healthy muscles during ageing. ‘We were excited to discover through collaborative research that a natural molecule from food cross-talks with cellular hallmarks of ageing. The benefits of trigonelline on cellular metabolism and muscle health during ageing opens promising translational applications,’ said Jerome Feige, Head of the Physical Health department at Nestlé Research.

The paper makes for worrying reading for ‘night owls’ compared to ‘early birds’ who are bright and breezy in the morning. Atherosclerosis involves fatty deposits accumulating on the inside of the arteries, making it harder for blood to pass through. The disease develops over a very long period of time and is not noticed until it leads to blood clots causing angina, heart attack, or stroke.

Previous research has shown that people with late-night habits have an increased risk of cardiovascular disease, but this is the first study to show how circadian rhythms specifically affect calcification of the arteries.

The study, published in the journal Sleep Medicine, involved 771 men and women aged between 50 and 64, all of whom are part of the larger population study SCAPIS. The degree of artery calcification in the heart’s coronary arteries was examined using computer tomography. Participants themselves indicated their so-called chronotype on a five-point scale: extreme morning type, moderate morning type, intermediate type, moderate evening type, or extreme evening type.

Of the 771 participants, 144 identified as extreme morning types, and 128 as extreme evening types. Among the group who were most alert in the morning, 22.2% had pronounced artery calcification – the lowest proportion of all five chronotypes. The extreme evening type group had the highest prevalence of severe coronary artery calcification, at 40.6%.

Mio Kobayashi Frisk, a doctoral student at Sahlgrenska Academy, University of Gothenburg, said the results indicate that extreme evening chronotype may be linked not only to poorer cardiovascular health in general, but also more specifically to calcification in the coronary arteries.

The statistical analysis considered a range of other factors that can affect the risk of atherosclerosis, including blood pressure, blood lipids, weight, physical activity, stress level, sleep, and smoking.

Ding Zou, a researcher at the University of Gothenburg said the results show that circadian rhythms are more significant early in the disease process. ‘It should therefore particularly be considered in the preventive treatment of cardiovascular diseases,’ says Ding Zou.