Biogen Inc. (BIIB.MX)
- Investor's Business Daily
Biogen Stock Tumbles After European Regulators Unexpectedly Reject Alzheimer's Drug
Biogen stock tumbled Friday after European regulators rejected its Eisai-partnered Alzheimer's treatment, citing steep side effects.
- Barrons.com
EU Rejection of Alzheimer’s Drug Is Another Disappointment for Biogen
European drug regulators rejected Biogen and Eisai request for approval of their Alzheimer’s medicine Leqembi, pointing to safety and efficacy issues that U.S. regulators looked past when they granted the drug full approval last year. The European Medicines Agency said Friday that it had recommended to the European Commission that it refuse marketing authorization within the European Union for Leqembi because of the drug’s limited benefits and the significant risks associated with it. “The observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events associated with the medicine,” the EMA said in a new document.
- Benzinga
Biogen/Eisai's Alzheimer's Drug Leqembi Gets 'No Go' From European Drug Regulator's Advisory Panel, Cites Serious Side Events
On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the approval of Eisai Co., Ltd (OTC:ESALY) (OTC:ESALF) and Biogen Inc.’s (NASDAQ:BIIB) lecanemab. The companies seek approval for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody as a treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD). The committee considered that the observed effect of Le
