Multiple Sclerosis

FDA Approves Novartis’ Kesimpta, the First and Only Self-Administered, Targeted B-Cell Therapy for Patients with Relapsing Multiple Sclerosis

Basel, August 20, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. …

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Novartis Announces NEJM Publication of Phase 3 Trials Demonstrating Superior Efficacy of Ofatumumab in Relapsing Multiple Sclerosis

Basel, August 5, 2020 — Novartis today announced that The New England Journal of Medicine (NEJM) published the positive results from the ASCLEPIOS I and II studies evaluating the safety and efficacy of ofatumumab (OMB157) 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with relapsing …

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Immunic Reports Positive Top-line Data from Phase 2 Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis

NEW YORK, Aug. 2, 2020 /PRNewswire/ — Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company’s selective oral DHODH …

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Dragonfly Therapeutics Collaborates with Bristol Myers Squibb to Develop Novel Therapeutics for Multiple Sclerosis and Neuro-inflammation Targets

WALTHAM, Mass., July 6, 2020 /PRNewswire/— Dragonfly Therapeutics, Inc. (“Dragonfly”), today announced a new research collaboration with Bristol Myers Squibb to discover and develop Dragonfly’s novel immunotherapies for multiple sclerosis and neuro-inflammation targets. Under the agreement, Dragonfly will grant Bristol Myers Squibb the option to license exclusive worldwide intellectual property …

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FDA Extends Review for Novartis’ sBLA for Ofatumumab in Patients with Relapsing Multiple Sclerosis

Basel, June 2, 2020 —  Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics License Application (sBLA) for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. Regulatory …

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Sanofi’s Investigational BTK Inhibitor Meets Primary Endpoint in Phase 2 Study in Relapsing Multiple Sclerosis

PARIS – February 6, 2020 – The Sanofi Phase 2b study evaluating its investigational BTK (Bruton’s tyrosine kinase) inhibitor (SAR442168), an oral, brain-penetrant, selective small molecule, achieved its primary endpoint. In the trial, SAR442168 significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging (MRI). SAR442168 …

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FDA Approves Allergan’s Botox for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy

DUBLIN, Oct. 24, 2019 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company’s supplemental Biologics License Application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP). This marks the 11th BOTOX® therapeutic …

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Mallinckrodt Announces Positive Top-Line Findings from its Registry Assessing Relapse Recovery in Multiple Sclerosis Relapse Patients Treated with Acthar Gel

STAINES-UPON-THAMES, United Kingdom, Oct. 1, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced positive top-line findings from its observational registry to assess treatment patterns and response to Acthar® Gel (repository corticotropin injection) in reducing the clinical impact of disease exacerbations in patients with multiple sclerosis (MS) relapse. The results for the …

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Sandoz Announces Global Deal to Commercialize Proposed Biosimilar Natalizumab

Holzkirchen, Germany, September 3, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under the agreement, …

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Novartis’ Ofatumumab Demonstrates Superiority Versus Aubagio in Two Head-to-Head Phase 3 Multiple Sclerosis Studies

Basel, August 30, 2019 – Novartis, a global leader in neuroscience, today announced positive results for ofatumumab (OMB157) from the Phase III ASCLEPIOS I and II studies. In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio®* (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS)[1]. The ASCLEPIOS studies investigated the efficacy …

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