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Ultomiris Approval History

Reviewed by J.Stewart BPharm Last updated on Dec 30, 2018.

FDA Approved: Yes (First approved December 21, 2018)
Brand name: Ultomiris
Generic name: ravulizumab-cwvz
Dosage form: Injection
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

  • Ultomiris is a new therapy for patients with PNH, and offers a much longer dosing interval compared to Soliris (eculizumab).
  • Ultomiris is administered as an intravenous infusion. The initial dose is a loading dose, followed by maintenance doses administered every 8-weeks. Patients are monitored for at least one hour following the completion of each infusion for signs or symptoms of infusion reactions.
  • The labeling for Ultomiris includes a boxed warning for serious meningococcal infections. Patients should be immunized against meningococcal disease, and monitored closely for early signs of meningococcal infections. Ultomiris is only available through a program called the Ultomiris REMS.
  • Ultomiris may also increase the risk of other types of serious infections including infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Patients prescribed Ultomiris will receive an Ultomiris Patient Safety Card that must be carried at all times. If Ultomiris is discontinued, patients may develop hemolysis due to PNH and must be monitored by their healthcare professional for at least 16 weeks following discontinuation. The Ultomiris Patient Safety Card must be carried for eight months after the last dose, because the increased risk of meningococcal infection persists for several weeks following discontinuation.
  • Ultomiris can cause serious side effects including infusion reactions. Common adverse drug reactions (>10%) were upper respiratory infection and headache.

Development History and FDA Approval Process for Ultomiris

Oct 18, 2019Approval Alexion Receives FDA Approval for Ultomiris (ravulizumab-cwvz) for Atypical Hemolytic Uremic Syndrome (AHUS)
Dec 21, 2018Approval FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Jun 19, 2018Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.

Further information

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