BLA 761108/S-021
Alexion Pharmaceuticals, Inc.
Attention: Leyla Toksoy
Director, Global Regulatory Affairs CMC
121 Seaport Boulevard
Boston, MA 02210
Dear Ms. Toksoy:
Please refer to your supplemental biologics license application (sBLA), dated and received September 23, 2021, and your amendments submitted under section 351(a) of the Public Health Service Act for Ultomiris (ravulizumab-cwvz) injection. We also refer to our approval letter dated July 22, 2022, which contained the following error: the REMS document was inadvertently omitted from the letter.
This corrected action letter incorporates the correction of the error. The effective action date will remain July 22, 2022, the date of the original letter.
This Prior Approval supplemental biologics license application provides for adding a new route of administration for Ultomiris via subcutaneous injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), and a new dosage form and strength, the Ultomiris 70mg/mL, 3.5 mL on-body delivery system. This supplement also provides for modifications to the approved Ultomiris risk evaluation and mitigation strategy (REMS).
APPROVAL & LABELING
We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling.
MANUFACTURING LOCATIONS
The final formulated 70mg/mL, 3.5 mL single-dose prefilled cartridge will be manufactured and filled at and tested for release at and at Alexion Pharma International Operations Unlimited Company, Alexion Dublin manufacturing Facility (ADMF), Dublin, Ireland.
