FDA records second original approval for Amgen's Pavblu
FDA's drug database shows a second original BLA approval for Pavblu, with the agency's approval letter dated October 23, 2026.
FDA records show a second original Biologics License Application for Pavblu, submitted by Amgen, with a submission status of approved as of October 22, 2026. The application, filed under BLA761298 as an ORIG 2 submission, lists a standard review priority and a submission status of AP (approved).1
The product itself is described in the filing as an injectable formulation. Pavblu's listed active ingredient is aflibercept-ayyh at a strength of 2 mg per 0.05 mL (40 mg/mL), administered by injection.1
The agency's approval letter associated with this submission carries a different date than the submission status update. The application documents include a letter dated October 23, 2026.1 The database record itself lists the broader submission status date as October 22, 2026, one day earlier than the letter's date, a discrepancy present in the source record.
The sponsor of record for this application is Amgen Inc.1 No further detail on the clinical basis for this second original approval, such as trial data or indication specifics, is included in this filing record. Readers should consult the full approval letter and any accompanying labeling documents for additional specifics on the approved use and conditions of approval.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.