Basel — Novartis today announced new Phase II data for iptacopan (LNP023), an investigational oral treatment for paroxysmal nocturnal hemoglobinuria (PNH), presented at the 26th Annual Congress of the European Hematology Association (EHA). In the study (NCT03896152), treatment with 12 weeks of iptacopan monotherapy was generally well tolerated with no...
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EAST HANOVER, N.J. – Novartis today announced that a Phase II study of investigational iptacopan (LNP023) – a first-in-class, oral, selective factor B inhibitor – in patients with C3 glomerulopathy (C3G) met primary endpoints in both patient cohorts[1]. The data were presented at the American Society of Nephrology (ASN) 2021...
EAST HANOVER, N.J. — Novartis today announced data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta® (ofatumumab) treatment for up to six years in recently diagnosed – defined as starting treatment within three years of initial diagnosis – treatment-naïve people living with relapsing multiple sclerosis...
Basel – Novartis today announced robust data from the primary analysis of the pivotal Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL)[1]. “Patients with follicular lymphoma who do not respond to their current treatment or who relapse early after treatment often have...
Basel – Novartis, a leader in rheumatology and immuno-dermatology, today announced 2-year positive results from the Phase III JUNIPERA study, demonstrating that Cosentyx® (secukinumab) significantly delayed time to flare vs placebo (P<.001) in pediatric patients with juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA) – two subtypes of juvenile idiopathic...
SINGAPORE – Novartis announced today that the Health Sciences Authority (HSA) has approved Kymriah (tisagenlecleucel) as the first commercial chimeric antigen receptor T-cell (CAR-T) therapy in Singapore under the new cell, tissue and gene therapy products (CTGTP) regulatory framework. Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two...
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...
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 — 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, 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...