Eisai Co., Ltd and Biogen Inc. have announced that they will seek re-examination of the negative opinion issued today by the Committee for Medicinal Products for Human Use (CHMP) on the marketing authorisation application for lecanemab.
Lecanemab, an anti-amyloid therapy for mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s dementia, has been approved by regulatory authorities in the US, Japan, China, South Korea, Hong Kong and Israel. On 26 July, the European Medicines Agency’s CHMP issued a negative opinion on the approval of lecanemab, stating that the benefits of treatment are not large enough to outweigh the risks associated with the drug.
Expressing their disappointment with the EMA decision, the manufacturers of lecanemab, Eisai and Biogen, issued a statement explaining that they will seek re-examination of the CHMP opinion. According to their procedural rules, the CHMP will have 60 days to re-examine their opinion, which can include consultation with a Scientific Advisory Group and an Oral Explanation to the Committee.
Read the full press release from Eisai and Biogen: https://www.eisai.com/news/2024/news202455.html