Sarepta Therapeutics’ gene therapy Elevidys will be available to Duchenne muscular dystrophy (DMD) patients who are at least 4 years old, regardless of whether they can walk, the FDA said Thursday.
Tag Archive for: full approval
In its second-quarter earnings report for fiscal year 2023, Eisai touted a sharp increase in the number of patients being treated with its Alzheimer’s disease therapy Leqembi (lecanemab).
Amgen’s regulatory ambitions for its non-small cell lung cancer drug Lumakras (sotorasib) ran into headwinds Tuesday, after FDA staff indicated in their briefing document that there might not be sufficient evidence of its efficacy to justify full approval.
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.
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.