Basel — Novartis announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA) and Type II Variation, respectively, for Kymriah® (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines...
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Basel, Switzerland – Novartis today announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition1-4. “C3G is a debilitating disease often affecting young people, impacting...
Basel — Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis...
Basel, Switzerland – Novartis today announced positive topline results from the Phase III STEER study. This pivotal study assessed the efficacy and safety of investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2, aged two to less than 18 years who are able...
Basel, August 12, 2025 – Novartis today announced positive top-line results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids1,2. Ianalumab plus eltrombopag, compared to placebo plus eltrombopag, significantly prolonged the time to treatment failure (TTF), the primary endpoint that assesses how...
Basel — Novartis announced today that the CANOPY-1 Phase III study did not demonstrate the statistically significant primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients treated with canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus...
Basel, Switzerland – Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally...
BASEL, Switzeland – The FDA on Wednesday approved Novartis’ oral drug iptacopan, a Factor B inhibitor now to be marketed under the brand name Fabhalta, for the treatment of adults with paroxysmal nocturnal hemoglobinuria. Designed to be orally available, Fabhalta is a small molecule inhibitor of Factor B, a key...
Basel, Switzerland – This week Novartis released topline results from the Phase III APPEAR-C3G study showing that its oral factor B inhibitor iptacopan significantly reduced protein in the urine of patients with C3 glomerulopathy, an ultra-rare and progressive kidney disease. In APPEAR-C3G, twice-daily treatment with 200-mg iptacopan—when given on top...
Basel, Switzerland – A new way to treat a painful skin condition shows promise in a phase 2 trial, according to a late-breaking presentation at the American Academy of Dermatology (AAD) Association annual meeting. Novartis’ remibrutinib was well tolerated and showed high responder rates compared with placebo in patients with...