ULTOMIRIS

批准信原文要点

The Ultomiris Prior Approval sBLA (BLA 761108/S-046) provides for a new indication for use of ravulizumab-cwvz to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

批准信原文要点

These Changes Being Effected in 30 days sBLA provides for proposed modifications to the approved Ultomiris and Soliris risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Prior Approval sBLA proposes withdrawal of the Ultomiris 300 mg/30 mL presentation (10 mg/mL).

批准信原文要点

Your proposed modifications to the REMS consist of removal of the Alexion REMS landing webpage from the REMS Document, and changes to the REMS Website (UltSolREMS.com).

批准信原文要点

The Soliris Prior Approval sBLA (BLA 125166/S-448) provides for a new indication for use of eculizumab for the treatment of generalized myasthenia gravis (gMG) in pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive.

批准信原文要点

This Prior Approval supplemental biologics application provides for a description of reports of liver enzyme abnormalities in the post marketing experience section of the USPI.

批准信原文要点

This Prior Approval sBLA removes the subcutaneous route of administration using the on-body delivery system (OBDS) device from the Prescribing Information and Medication Guide labeling.

批准信原文要点

Prior Approval sBLA S-26 provides for a new indication for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive and proposed modifications to the approved Ultomiris REMS.

批准信原文要点

We also refer to our letter dated November 13, 2023, notifying you, under Section 505(o)(4) of the FDCA, of new safety information ... risk of serious meningococcal infections.

批准信原文要点

This corrected action letter incorporates the correction of the error. This Prior Approval supplemental biologics license application provides for adding a new route of administration for Ultomiris via subcutaneous injection ... 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 REMS.

批准信原文要点

This Prior Approval supplemental biologics license application provides for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and proposed modifications to the approved Ultomiris REMS.

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides the following changes to the Prescribing Information: 1. Information regarding anaphylaxis and hypersensitivity reactions was added to section 5.5 infusion-related reactions. 2. Information regarding infusion-related reactions was added to section 6.1 clinical trial experience. 3. Information regarding anaphylaxis was added to section 6.3 postmarketing experience

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for proposed modifications to the approved Ultomiris risk evaluation and mitigation strategy (REMS).

批准信原文要点

This Prior Approval supplemental biologics application provides for the treatment of pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides a revision on the top panel of the 3 mL carton (NDC 25682-025-01). The top panel of the 3 mL carton states “30 mL Single-dose vial” where it should correctly state “3 mL Single-dose vial”.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new concentration, 100 mg/mL, with two vial presentations: 300 mg/3 mL and 1100 mg/11 mL, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

批准信原文要点

Your proposed modifications to the REMS consist of changes to the Prescriber Enrollment Form to include the prescriber specialty and reformat this form from two pages to one page.

批准信原文要点

This Prior Approval supplemental biologics application provides for a new indication for the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).