Regulation & Policy

The Alzheimer’s disease drug, Leqembi (lecanemab), has been approved by the European Commission following extra reviews of the product’s safety. The decision was announced on 16 April by the product’s co-developer BioArctic AB which will make the drug available to adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease. The patient group is specifically identified as people who have only one, or no copy, of the ApoE4 gene, a risk factor for the disease. 

A vaccine designed to prevent disease caused by the chikungunya virus, a mosquito-borne virus, has been approved in Brazil, an endemic country. Developed by Valneva SE of France, the vaccine IXCHIQ, is intended for individuals 18 years and older. Chikungunya disease, which causes muscle pain and joint swelling, has occurred in Africa, Asia, the Americas, Europe and islands in the Indian and Pacific oceans. According to the US Centers for Disease Control and Prevention, there is a risk that the virus could spread to unaffected areas by travellers.

Five medicinal products, each with multiple indications, have been assessed by scientific experts who are supporting the African Medicines Agency, a prospective regulatory authority for countries in the African Union. The medicines are all vaccines, some of which are indicated for cancers, and others for infectious diseases. The products are generic versions of well-established drugs, including bavencio, gardasil and pembrolizumab, and protect against diseases ranging from diphtheria and tetanus to non-small cell lung and colorectal cancers. 

The European Commission has outlined a strategy for building capacity in artificial intelligence across the 27-nation union alongside the first grants to execute it. Announced on 9 April, the strategy envisions the construction of new AI data centres and laboratories, the use of new algorithms, and the recruitment of skilled labour. 

A new drug for haemophilia that targets antithrombin, a protein that inhibits blood clotting, has been approved by the US Food and Drug Administration. Discovered by Alnylam Pharmaceuticals Inc and licensed to Sanofi SA, Qfitlia (fitusiran) will be used to treat patients with both haemophilia A and haemophilia B with or without inhibitors. The standard treatment for patients with haemophilia are clotting factor replacement therapies where patients with haemophilia A receive replacement for factor VIII and those with haemophilia B, replacement for factor IX.

Effective 7 April, the US Food and Drug Administration had lost 28 senior leaders who left the agency voluntarily or were fired following the Trump Administration’ decision to reduce the workforce by 3,500 people. The figures, compiled by the STAT news agency, show that departures included deputy directors and commissioners across all departments from the centres for devices and radiological health, to the centres for small molecule and biologic evaluation, and for tobacco regulation.

The US Food and Drug Administration announced plans on 10 April to phase out animal testing for monoclonal antibodies and other drugs – a safety requirement for the development of human medicines that was first introduced in 1938. The reason is to adopt new methods for evaluating safety that could harness technologies such as artificial intelligence while reducing research and development costs.

Only hours before announcing countermeasures against prospective US tariffs on steel and aluminium, the European Commission has pulled back in response to a pause from the Trump Administration. The US announced a 90-day pause on its tariff measures on 9 April. The pause affects a second tier of tariffs that would have driven the tax on exports by the US’ trading partners up by double-digit figures. The pause does not affect China.

The European Union member states have agreed to enact countermeasures against US tariffs on steel and aluminium from 15 April should negotiations over trade fail to reach a fair and balanced outcome by that time, the European Commission announced on 9 April. The vote by member states gave support to a proposal from the Commission in response to a US decision in March to impose import duties on the two products.

The European Medicines Agency issued a negative opinion on 28 March to Eli Lilly and Co which applied to market its Alzheimer’s treatment Kisunla (donanemab) in the EU for patients with amyloid beta plaques in the brain and mild cognitive impairment. Lilly said that it will appeal against the decision.