The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November ...
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia ...
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a ...
In Japan, clinical use is climbing faster, with about 4,500 people now on the drug. ARIA rates in Japan are half those in the U.S., which was also the case in the Phase 3 Clarity trial. Meanwhile, use ...