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.
Eisai (ESAIY) and Biogen (BIIB) announced that a positive opinion has been received from the Committee for Medicinal Products for Human Use of ...
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Ozempic and Viagra, among the more than 80 drugs expected to work against Alzheimer's in the coming yearsToday, the first monoclonal antibodies, lecanemab and donanemab, are available, showing that their reduction effect on ...
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 ...
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai ...
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Alzheimer's Data WithdrawnA preprint research letter linking the Alzheimer's drug lecanemab (Leqembi) with excess deaths was withdrawn last week. The ...
Four anti-amyloid antibodies—lecanemab, aducanumab, gantenerumab, donanemab—cleared plaque from the brain in Phase 3 trials, but only two went on to receive traditional U.S. marketing approval. What ...
Results from the open-label long-term extension study (OLE) following the core study of the lecanemab phase 3 Clarity AD study presented at AAIC in July, showed that the mean change from baseline ...
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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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