Drug licence refused

A decision by the European Medicines Agency (EMA) to refuse a licence for the dementia drug aducanumab has been described as “bitterly disappointing news for people with Alzheimer’s disease.”

Alzheimer’s Research UK chief executive Hilary Evans made the comment after the EMA rejected an application by the manufacturer Biogen to distribute the drug across the European Union.  It is not known whether Biogen will make a similar application to the UK regulator, the MHRA, to license the drug here.

The EMA turned down the application despite the fact that aducanumab – known commercially as Aduhelm – has been approved for use in the USA for people with mild cognitive impairment or mild Alzheimer’s disease.

In its ruling the agency agreed that the drug does reduce Alzheimer’s trademark amyloid protein in the brain but said that the link between this and clinical effect was unproven. Nor did the studies show the drug was sufficiently safe since there was evidence in some cases of brain swelling or bleeding.

Evans added: “Biogen must continue collecting essential data to clarify the safety and effectiveness of aducanumab.  While further data collection is happening in the US, the UK is uniquely well placed to deliver world-class clinical studies that could address unanswered questions about the drug.”