The Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Adopted Negative Opinion On Approval Of Eisai/Biogen's Lecanemab As Treatment For Early Alzheimer's Disease, Eisai Said It Will Seek Re-Examination Of The Opinion
Portfolio Pulse from Benzinga Newsdesk
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a negative opinion on the approval of Eisai and Biogen's Lecanemab for early Alzheimer's treatment. Eisai plans to seek re-examination and work with authorities to make the treatment available in the EU.
July 26, 2024 | 11:24 am
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a negative opinion on Biogen and Eisai's Lecanemab for early Alzheimer's treatment. This could delay the drug's availability in the EU, impacting Biogen's revenue projections.
The negative opinion from the EMA could delay the approval and market entry of Lecanemab in the EU, potentially affecting Biogen's revenue from this drug. Investors may react negatively to this news.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
NEGATIVE IMPACT
Eisai faces a setback as the EMA's Committee for Medicinal Products for Human Use adopts a negative opinion on Lecanemab for early Alzheimer's. Eisai plans to seek re-examination, but the delay could impact its market strategy in the EU.
The negative opinion from the EMA could delay Lecanemab's approval and market entry in the EU, affecting Eisai's market strategy and potential revenue from this drug. This news is likely to be viewed negatively by investors.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100