FDA Advisors Evaluate Whether Alzheimer's Drug Leqembi Should Get Full Approval
(RTTNews) - A panel of independent advisors convened by the Food and Drug Administration is currently meeting to determine whether Leqembi, an Alzheimer's drug developed by Eisai and Biogen, should receive full approval.
Although the FDA is not obligated to follow the advisors' recommendation, a favorable vote would potentially pave the way for the treatment's approval later this summer.
The FDA is expected to make a final decision on Leqembi on July 6, which will directly influence whether Medicare provides comprehensive coverage for the medication. Currently, Medicare has significantly restricted coverage due to the drug's previous expedited approval process.
Leqembi marks the second Alzheimer's treatment from Eisai and Biogen to undergo FDA review, following the controversial approval of the drug Aduhelm in the summer of 2021. Despite 10 out of 11 advisory committee members concluding that Aduhelm did not demonstrate clinical benefit, the regulatory body granted it expedited approval. Subsequently, a congressional investigation revealed irregularities surrounding the approval process of Aduhelm.