ALHEMO

批准信原文要点

This Prior Approval sBLA provides for the submission of updated Prescribing Information, Medication guide, and Instructions for Use labeling with expanded indications for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors. This submission supports the administrative closure and merger of BLA 761428 into parent BLA 761315.

批准信原文要点

We have approved your BLA for Alhemo (concizumab-mtci) effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Alhemo, under your existing Department of Health and Human Services U.S. License No. 1261.