ESALF - Biogen Eisai's Alzheimer's treatment lecanemab approved by the FDA

NOTE: This story will be updated throughout the day as additional information becomes available.

• The US FDA on Friday approved Biogen ( NASDAQ: BIIB ) and Eisai's ( OTCPK:ESALY ) Alzheimer's therapy lecanemab, which will be marketed as Leqembi.
• The approval of Leqembi is a triumph for Biogen ( BIIB ) and Eisai ( OTCPK:ESALF ) given that their already approved Alzheimer's therapy, Aduhelm (aducanumab), has largely been ignored due to lack of Medicare coverage and questions over its efficacy .
• CMS will need to make a National Coverage Determination on coverage for lecanemab.
• In the phase 3 CLARITY AD study, lecanemab 10 mg/kg biweekly treatment led to significantly reduced decline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale of 27% versus placebo over 18 months. Using the same scale, Aduhelm produced a 22% decline.
• Although it has been approved, a concern likely on the minds of many clinicians is lecanemab's safety record. The biologic has been associated with brain swelling and bleeding in some patients. In December, lecanemab was linked to a third patient death in a trial .

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