EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval for Eisai and Biogen's Leqembi in some patients with early Alzheimer's disease, nearly four months after it first rejected the treatment.
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be approved.
European agency switches to recommending new Alzheimer's drug
The European Medicines Agency said Thursday that its committee evaluating medical products has recommended partial approval of sales of lecanemab to treat Alzheimer's disease. The committee of the pharmaceuticals watchdog had shown a negative opinion in July on the medicine, developed by drugmakers Eisai of Japan and Biogen of the United States.
EMA changes tune, endorses Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
EU Gives Green Light: Leqembi on the Verge of Alzheimer's Approval
The EU's drugs regulator recommends approval of Eisai and Biogen's Alzheimer's drug, Leqembi, for patients with early stages of the disease. The approval is limited to those with certain genetic profiles.
EU regulator backs Eisai-Biogen Alzheimer’s drug
EU drugs regulator recommends approval of Leqembi for early Alzheimer's, pending European Commission acceptance, for specific patient group.
Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease drug that the company developed with Japanese partner Eisai — reversing an earlier decision not to approve the drug.
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with early Alzheimer's disease, months after the agency first rejected the treatment.
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at slowing cognitive decline in patients. In July, the Amsterdam-based European Medicines Agency (EMA) denied recommending approval of the drug made by Eisai and Biogen because it considered the risks - especially bleeding and swelling in the brain - to be greater than the potential benefits in a broad population.
Eisai Gets Positive Opinion From CHMP In European Union For Lecanemab In Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
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EU Backs Leqembi: A Breakthrough in Alzheimer's Treatment
The European Union's drugs regulator has recommended approval for Eisai and Biogen's Alzheimer's drug Leqembi. This marks a ...