The company announced Monday its shareholders elected Susan Langer, current president of Souffle Therapeutics, to its board of directors, replacing her reputed romantic partner Alex Denner.
Tag Archive for: Biogen
The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co. Ltd. and Biogen Inc.’s new Alzheimer’s drug Leqembi, should it win traditional U.S. approval as expected by July 6.
Last week, an FDA advisory committee gave Eisai and Biogen’s Alzheimer’s drug Leqembi (lecanemab) its unanimous blessing for traditional approval, signaling it will likely become the first drug of its class to receive this classification. While this is positive news for the biopharma partners and Alzheimer’s patients, concerns linger about the drug’s safety and Medicare coverage.
In its most recent leadership shake-up, the company announced that three of its directors and its board chair will not stand for re-election at Wednesday’s annual stockholder meeting.
In Europe, where cost-conscious countries rigorously weigh new drugs before adopting their use, nine neurologists and researchers across six countries told Reuters lecanemab is unlikely to be widely used if approved. Their views underpin analyst estimates suggesting Europe will be a small market for the drug.
Shares of Biogen rose 4% in premarket trade on Monday as an unanimous backing of the company’s Alzheimer’s drug Leqembi by the U.S. regulator’s advisers eased concerns that a traditional approval for the treatment will not come with major new safety warnings.
Today a panel of experts will discuss whether to recommend traditional U.S. regulatory approval for Eisai and Biogen’s new Alzheimer’s drug Leqembi, a move expected to expand Medicare payment for the treatment.
U.S. Food and Drug Administration staff on Wednesday said data from a late-stage trial of Eisai and Biogen’s Alzheimer’s disease drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval.
The recent FDA approval of Biogen’s Qalsody for superoxide dismutase 1 (SOD1)–ALS highlighted the potential for antisense oligonucleotides in central nervous system diseases. But the recent failure of Wave Life Sciences’ WVE-004 in C9orf72–ALS also showed their limitations.
The Medicare health plan will cover new Alzheimer’s drugs after full U.S. approval for patients who participate in a health agency database, a move that expands on conditional coverage terms but companies have said that would limit use.
