Basel, Switzerland – Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease2. Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits...
treatment News
Basel, Switzerland – Novartis today announced positive results from VAYHIT2, a Phase III trial evaluating ianalumab plus eltrombopag in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids1-3. Ianalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45%, based on the primary endpoint of time to treatment failure (TTF), which assesses...
LEXINGTON, Mass. — Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced a strategic collaboration and capsid license agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS) to advance potential gene therapies for Huntington’s disease (HD) and spinal muscular atrophy (SMA)....
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...
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, Switzerland – Novartis announced positive safety and efficacy results from the Phase III program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to <18 years with spinal muscular atrophy (SMA). In the Phase III STEER study, treatment with OAV101 IT led to...
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...