Prospects for Full Approval of Eisai and Biogen's Leqembi Shine Brighter after FDA Committee Vote
Portfolio Pulse from Vandana Singh
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously in favor of Eisai and Biogen's Leqembi for Alzheimer's disease, confirming its clinical benefit. The committee also confirmed the overall benefit-risk profile of Leqembi and the clinical meaningfulness of the data.
June 12, 2023 | 6:01 pm
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POSITIVE IMPACT
Biogen's Leqembi received unanimous support from the FDA committee for its clinical benefit in Alzheimer's disease, increasing the likelihood of full approval by the July 6 PDUFA date.
The FDA committee's unanimous support for Leqembi's clinical benefit and overall benefit-risk profile directly impacts Biogen, as it increases the likelihood of full approval by the July 6 PDUFA date. This positive news is likely to boost investor confidence in the company and its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100
POSITIVE IMPACT
Eisai's Leqembi received unanimous support from the FDA committee for its clinical benefit in Alzheimer's disease, increasing the likelihood of full approval by the July 6 PDUFA date.
The FDA committee's unanimous support for Leqembi's clinical benefit and overall benefit-risk profile directly impacts Eisai, as it increases the likelihood of full approval by the July 6 PDUFA date. This positive news is likely to boost investor confidence in the company and its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100