European Regulators Reject Eisai and Biogen’s Alzheimer’s Drug Leqembi
1. Rejection by European Regulators: The European Medicines Agency's human medicines committee has rejected Eisai and Biogen's Alzheimer's drug Leqembi, citing that the benefits of delaying cognitive decline do not outweigh the risks of serious side effects.
2. Reason for Rejection: The committee stated that the drug's effect on slowing cognitive deterioration does not sufficiently counterbalance the potential for significant adverse effects linked to the medication.
3. Impact on Companies: This rejection is a blow to Eisai and Biogen, who were seeking to expand sales in the European market, one of the world's largest drug markets.
4. Previous Setback: This is not the first setback for the companies; their first commercialized Alzheimer's medicine, Aduhelm, was refused coverage by Medicare.
5. Analyst's View: An analyst has downplayed the rejection, calling it merely a "delay" in the drug's approval process.