On 1 April, Eisai and Biogen announced that the European Commission has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee.
Lecanemab received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2024 and is currently awaiting its Marketing Authorisation Application (MAA) by the European Commission. The EMA positive opinion on lecanemab was recently reaffirmed following discussions at the February CHMP meeting. Lecanemab has been approved by regulatory authorities in China, Hong Kong, Israel, Japan, Mexico, South Korea, the United Arab Emirates, the UK and the US.
At its latest meeting, the Standing Committee on Medicinal Products for Human Use of the European Commission discussed the approval of lecanemab, based on the same scientific opinion of the CHMP recommending the marketing authorisation of lecanemab. The committee voted with a ‘no opinion’ outcome. In view of that vote, the European Commission informed the companies that it will convene an Appeal Committee within four weeks from the present vote, to make a final decision on the marketing authorisation for lecanemab.
You can read the press release of Biogen here: https://investors.biogen.com/news-releases/news-release-details/update-regulatory-review-lecanemab-early-alzheimers-disease-2
