What was the basis of accelerated approval, and what clinical benefit still required confirmation?
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Biogen reported FDA acceptance and priority review of the tofersen application, with a target action date of January 25, 2023. Acceptance for review was not approval.
Biogen announced a new FDA target of April 25, 2023. It said responses to FDA information requests were considered a major amendment requiring additional review time.
Ionis announced that its partner Biogen received accelerated FDA approval for QALSODY in adults with SOD1-associated ALS. The approval used a biomarker endpoint; continued approval could depend on confirmation of clinical benefit.
These selected company announcements preserve publication dates separately from ORION’s later recording times. Registry completion dates and follow-up research questions are separate from company announcements; this historical release does not establish current guidance or continuous monitoring.