Expanded Medicare Coverage For Biogen-Eisai's Leqembi Signals a Turning Point in Alzheimer's Treatment: Analysts

The FDA approved a supplemental marketing application for Biogen Inc BIIB-Eisai Co Ltd ESALY supporting the traditional approval of Leqembi (lecanemab-irmb), making it the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease. 

In January, the FDA approved Leqembi via the Accelerated Approval pathway.

Concurrently, CMS confirmed broader Medicare coverage is now available for Biogen and Eisai's Leqembi.

William Blair writes that the approval of Aduhelm has been followed by disappointment from a launch and payer-approval perspective for Biogen, resulting in a focus shift toward Leqembi. 

Beyond Leqembi, the company could have success with additional pipeline assets in depression, ALS, and Parkinson's disease.

Raymond James says, given that the AdCom panel deferred making any declarative statements on risks to specific patient populations, the FDA omitted any overt labeling restrictions but did put narrative warnings about the potential risks.

Oppenheimer analyst says reimbursement dynamics could favor Leqembi for ApoE4 heterozygotes if donanemab has significantly higher rates of ARIA in those patients. More details on donanemab efficacy and safety stratified by ApoE4 status are expected at AAIC.

Needham says that while the black box warning and safety commentary in the updated label may be a shade more precautionary than some may have expected, but CMS registry for broad access should be viewed positively. 

The analyst says these developments would not meaningfully change the outlook for Leqembi, for which the investors are not expecting a rapid sales ramp. The analyst says the upcoming earnings will be more focused on cost optimization, business development, and its broader R&D pipeline. 

Price Action: BIIB shares are down 2.72% at $277.75 on the last check Friday.