Alzheimer’s drug hits a barrier in EU – what does the news mean?

Regulators across the world are grappling with what to do about new medicines for early Alzheimer’s disease. Today, an expert committee for the European regulator the European Medicines Agency (EMA) decided not to approve lecanemab (also known as Leqembi) for the treatment of early Alzheimer’s disease, as in its view, the benefits were not large enough to outweigh the risks.

At Alzheimer’s Research UK, we’re keenly keeping track of how lecanemab is being scrutinised by global regulators. The drug has already been approved in the US, Japan, China, Hong Kong, Israel and South Korea, but today’s news from the EMA committee will mean that patients in the EU will not be able to receive it in the near future.

While we’re eagerly awaiting news from the MHRA, this week our attention’s been focused on the EMA, and its two-step process.

The first step in the EMA’s decision-making process is taken by a body called The Committee for Medicinal Products for Human Use (CHMP) – the EMA’s committee responsible for assessing medicines. This week, it met to look at the data on lecanemab, in order to make a recommendation over whether it should be granted an EU license.