Novartis updates Zortress label; advances Fanconi anemia and IgAN trials
Novartis logs a Zortress labeling supplement approval, posts results for an eltrombopag Fanconi anemia study, and sees new real-world and mechanistic trials tied to ofatumumab and atrasentan.
Four items moved this week across Novartis's regulatory and trial pipeline.
- Zortress (everolimus) tablets received a standard-review labeling supplement, submission number 34, which was approved.1 The approval letter is dated September 21, 2026 and the updated label is dated September 22, 2026, per the application documents.
- A National Heart, Lung, and Blood Institute-sponsored Phase 2 study of eltrombopag in Fanconi anemia, with Novartis as a collaborator, posted results. The trial treated patients with Fanconi anemia for 6 months with eltrombopag to assess safety and efficacy at improving hematological manifestations of the disease.2 Enrollment reached 25 participants in the single-group Phase 2 study.2
- Novartis Pharmaceuticals is sponsoring a new observational study of ofatumumab in relapsing multiple sclerosis. The study evaluates real-world persistence and adherence to ofatumumab treatment in adult patients with relapsing multiple sclerosis, using administrative claims data from Germany and Japan.3 Estimated enrollment is 5000 participants.3
- A Phase 4 mechanistic study of atrasentan in IgA nephropathy, sponsored by the University of Illinois at Chicago with Novartis as a collaborator, is not yet recruiting. The single-arm, open-label study evaluates atrasentan added to optimized supportive care on kidney structure and function, with approximately 20 participants receiving atrasentan 0.75 mg orally once daily for 52 weeks.4
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.