Biogen (BIIB) and Eisai said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use reaffirmed its positive opinion on lecanemab for early Alzheimer's disease, allowing the European Commission to resume its review of the drug's marketing application.
The companies said the European Commission had asked the committee to reassess lecanemab's safety data and risk minimization measures after issuing its initial opinion in November. The committee determined that no changes were needed, according to the joint statement.
Eisai leads the drug's global development and regulatory process, with Biogen co-commercializing and co-promoting it, the companies said.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.