Lecanemab

EMA recommends EU approval of Leqembi, the first Alzheimer’s treatment that slows disease progression, for patients with one or no ApoE4 gene copy. The treatment, made by Eisai and Biogen, was previously rejected due to high side effect risks.

EU drugs regulator recommends Eisai and Biogen’s Leqembi for early Alzheimer’s patients with one or no ApoE4 gene variant, reversing earlier rejection due to brain swelling risks.

EMA approves Eisai/Biogen's Alzheimer's drug Leqembi after initial rejection, with recommendations for initial generic screening and ongoing safety monitoring.

EMA now supports Leqembi approval in Europe for mild Alzheimer’s patients with low ARIA risk, reversing earlier safety concerns. This decision could boost sales, with 20% from Europe, despite potential reimbursement hurdles and lower pricing.

The European Medicines Agency's Committee for Medicinal Products for Human Use now recommends approval of lecanemab, an Alzheimer’s treatment, after initially rejecting it due to concerns over side effects. Developed by Eisai and co-marketed with Biogen, lecanemab clears brain plaque and has shown to slow memory decline in a large study. Separately, Ford Motor Co. faces a $165 million penalty from the U.S. government for slow recall response and inaccurate information on faulty rearview cameras.

Europe's EMA partially approves Leqembi for mild Alzheimer's, limited to patients with one or no ApoE4 gene copy, due to lower risk of brain bleeding.

The European regulatory committee now recommends approval of lecanemab, known as Leqembi in the U.S., for early Alzheimer’s treatment, reversing a previous rejection due to side effect concerns. Developed by Eisai and co-marketed with Biogen, Leqembi clears brain plaque and has shown to slow cognitive decline, though it can cause brain swelling and bleeding. The drug has already received full approval from the U.S. FDA and other countries.

The EMA’s CHMP now recommends Leqembi for Alzheimer’s patients with mild cognitive impairment or mild dementia, provided they carry one or no copies of the ApoE4 gene variant, due to lower ARIA risk. The EMA is expected to decide on Leqembi’s marketing authorisation in January 2025.