Biogen, Eisai's Alzheimer's treatment lecanemab approved by the FDA
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NOTE: Updated with information about Leqembi availability and price.





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.
Leqembi is given via infusion twice per month. Eisai said that it will be available during or before the week of Jan. 23.
The Japanese drugmaker also said the drug has a wholesale acquisition cost of $26.5K per year. That's slightly lower than the $28.2K charged for Aduhelm, though that therapy was originally priced at $56K.
The drug's prescribing information states that the treatment is for those with mild cognitive impairment or mild dementia as there is no data on its use in those with earlier or later stages of the disease.
It also includes a warning to monitor for Amyloid Related Imaging Abnormalities (ARIA) -- characterized by brain swelling and bleeding -- during the first 14 weeks of treatment. 
CMS will need to make a National Coverage Determination on coverage for lecanemab.
Trading in Biogen (BIIB) was halted at 2p ET.
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. In December, lecanemab was linked to a third patient death in a trial.