Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Apr 21
- 2 min read
Updated: Apr 22
21/04/2026
FDA accepted application for Roche’s Gazyva for the treatment of SLE (Ref)
Roche announced that the US FDA had accepted a supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment of patients with systemic lupus erythematosus (SLE).
The filing acceptance was based on positive results from the phase 3 ALLEGORY/ NCT04963296 study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks.
The FDA was expected to make a decision on approval by December 2026.
Cristcot announced FDA acceptance of NDA for ngHCA for treatment of UC of the Rectum (Ref)
Cristcot announced that the US FDA had accepted the company’s New Drug Application (NDA) under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its next-generation hydrocortisone acetate (ngHCA) 90 mg suppository administered via the Sephure® suppository applicator.
The NDA was supported by positive results from the Phase 3, CESSA trial, which achieved its primary endpoint of clinical remission based on the Modified Mayo Score of 0-2 at Day 29.
The FDA has set a PDUFA target date in October 2026.
AstraZeneca announced Phase 3 results for ravulizumab for IgA Nephropathy (Ref)
AstraZeneca announced positive results from a prespecified interim analysis of the Phase 3, I CAN trial for Ultomiris (ravulizumab; C5 complement inhibitor) for the treatment of adult patients with immunoglobulin A nephropathy (IgAN).
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction of proteinuria, based on 24-hour urine protein creatinine ratio (UPCR) at week 34.
The safety profile observed in this trial was consistent with the known profile of Ultomiris, with no new safety concerns identified.
