Regulation & Policy

The European Medicines Agency is to update the side effect profile for semaglutide following evidence from epidemiological studies that use of the drug is associated with a very rare eye condition known as non-arteritic anterior ischaemic optic neuropathy (NAION). This may cause loss of vision. The decision was announced on 6 June and will affect the labelling of three approved semaglutide products, Ozempic, Rybelsus and Wegovy. All three are produced by Novo Nordisk A/S and are on the market in the EU.

People suspected of having Alzheimer’s disease will in future be able to have another option for receiving a confirmed diagnosis following the approval of a new blood test by the US Food and Drug Administration. The approval, announced on 16 May, is for an in vitro diagnostic device, the first of its kind. It is called the Lumipulse G pTau217/beta-amyloid 1-42 plasma ratio. The developer is Fujirebio Diagnostics Ltd of Japan.

Efpia, the federation that represents pharmaceutical companies in Europe, has deferred comment on President Donald Trump’s executive order on 12 May which is intended to lower the prices of prescription drugs in the US. The order would introduce the Most Favoured Nation policy to drugs. This is a principle of the World Trade Organization under which all nations treat their trading partners equally. In the context of the Trump order, it is being interpreted to mean that US drug prices would be tied to those set in other countries.

A new nonsteroidal treatment for Duchenne muscular dystrophy (DMD) has been recommended in Europe for a conditional marketing authorisation to treat patients from the age of six. The drug, Duvyzat (givinostat), was approved by the US Food and Drug Administration in 2024. It was given a positive opinion by the European Medicines Agency on 25 April. Duvyzat is an oral suspension to be taken at the same time as corticosteroid, the current standard of care. The EMA is recommending the drug for patients who can still walk.

The European Commission has disclosed a list of potential countermeasures against tariffs imposed by the US should trade negotiations between the two parties fail to reach a mutually beneficial outcome. The measures were submitted to companies and other stakeholders for review on 8 May.

Scientific research across all sectors in the EU will receive more financial support under a plan announced on 5 May by Ursula von der Leyen, president of the European Commission. Speaking at an event at the Sorbonne University in Paris, President von der Leyen outlined four new policies to support research. The first is €500 million in new research funding covering the period from 2025 to 2027. Under this programme, it will be possible for researchers to apply for a new ‘super grant’ giving them seven years of financial support.

Blenrep (belantamab mafodotine), an antibody-drug conjugate given speedy approvals in both  the US and the EU in 2020, and later withdrawn for insufficient efficacy, has won approval for a new market entry in the UK on the basis of two combination studies. The drug was developed by GSK Plc to treat patients with relapsed or refractory multiple myeloma, the third most common blood cancer globally.

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.