FDA Signals Support for Eisai-Biogen Alzheimer's Drug Data Confirms Benefits For Complete Approval
Portfolio Pulse from Vandana Singh
The FDA has signaled support for Eisai and Biogen's Alzheimer's drug, Leqembi (lecanemab), after data from the Phase 3 Study 301 confirmed its clinical benefits. The drug has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6. Traditional approval is expected to boost demand for Leqembi and broaden insurance coverage under the U.S. government's Medicare plan.
June 08, 2023 | 12:34 pm
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Biogen's Alzheimer's drug Leqembi, developed in collaboration with Eisai, has received FDA support after Phase 3 study data confirmed its clinical benefits. Traditional approval is expected to boost demand and broaden insurance coverage.
The FDA's support for Leqembi, developed by Biogen in collaboration with Eisai, is a positive signal for the drug's approval. The Phase 3 study data confirmed its clinical benefits, and traditional approval is expected to boost demand and broaden insurance coverage under the U.S. government's Medicare plan. This is likely to have a positive short-term impact on Biogen's stock price.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100
POSITIVE IMPACT
Eisai's Alzheimer's drug Leqembi, developed in collaboration with Biogen, has received FDA support after Phase 3 study data confirmed its clinical benefits. Traditional approval is expected to boost demand and broaden insurance coverage.
The FDA's support for Leqembi, developed by Eisai in collaboration with Biogen, is a positive signal for the drug's approval. The Phase 3 study data confirmed its clinical benefits, and traditional approval is expected to boost demand and broaden insurance coverage under the U.S. government's Medicare plan. This is likely to have a positive short-term impact on Eisai's stock price.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100