FDA grants traditional approval for Eisai-Biogen’s Alzheimer’s therapy

Pharmaceutical Technology·Jul 7

✦ NabkaNews BriefAuto-summarized from multiple outlets · verify with the source

The FDA has granted traditional approval for Eisai-Biogen's Alzheimer's therapy, lecanemab, which is also known as Leqembi. This approval may lead to expanded coverage, including by Medicare, although some limitations on coverage may still apply. Health Canada has also granted authorization for Leqembi for the treatment of early Alzheimer's disease.

Full coverage

Health Canada Grants Authorization for “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease

Biogen·Oct 26

With Full FDA Approval, Alzheimer’s Drug Leqembi Now Covered By Medicare

Being Patient·Aug 2

Health Canada Grants Authorization for LEQEMBI® (lecanemab) for the Treatment of Early Alzheimer's Disease

Newswire Canada·Oct 27

US FDA grants standard approval of Eisai/Biogen Alzheimer's drug

Reuters·Jul 7

With full Alzheimer's approval in hand, Eisai and Biogen kick off Leqembi's launch in earnest

Fierce Pharma·Jul 6

FDA: Specific Fast Track Designation for Subcutaneous Formulation of Leqembi for Alzheimer Disease Needed for Rolling Review

Psychiatric Times·Apr 3

FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

Biogen·Jul 6

Medicare keeps limits on Alzheimer’s drug coverage, but loosens policy

BioPharma Dive·Jun 1

View original report at Pharmaceutical Technology ↗

Fetching the latest headlines…