What did the FDA review extension cover, and which patients are included in the resulting approval?
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BioMarin reported a March 31, 2023 FDA target action date and explicitly said a three-month extension was possible if FDA considered it necessary. The date was a review target, not a promise of approval.
Stated timing: March 31, 2023; potential three-month extension disclosed
BioMarin reported that FDA had extended the review in March and set June 30, 2023 as the new target. The company said the requested three-year study analysis constituted a major amendment. This source does not identify the exact day in March when the change occurred.
BioMarin announced FDA approval of ROCTAVIAN for eligible adults with severe hemophilia A on June 29, 2023. The announcement contains eligibility and safety information; approval should not be read as suitable treatment for every patient.
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.