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Eisai’s Leqembi Launch Bodes Well For Biogen In A Pivotal Year

Executive Summary

Eisai said the US launch of Alzheimer’s therapy Leqembi following accelerated approval is going well, which is welcome news for partner Biogen as it brings on a new CEO and recovers from a failed Aduhelm launch.

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Eisai/Biogen’s Leqembi Will See Broadened Access To Majority Of Patients

CMS will cover Leqembi now that the US FDA has converted Leqembi’s accelerated approval to traditional approval, giving most patients eligible for treatment access to the drug. Updated labeling puts greater emphasis on safety concerns.

ICER’s Leqembi Assessment Inches Higher, Still Sees Eisai Price As Too High

The drug pricing watchdog said in its revised report that Alzheimer’s therapy Leqembi (lecanemab) meets cost-effectiveness thresholds at $8,900-$21,500, below Eisai/Biogen’s $26,500 list price.

UPDATED: US FDA Has People Working At CMS To Help Implement Inflation Reduction Act

The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.

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