Multiple Sclerosis

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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Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis

DUBLIN, Ireland and CAMBRIDGE, Mass., July 30, 2019 (GLOBE NEWSWIRE) — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced positive topline results from EVOLVE-MS-2, a large, randomized, double-blind, five-week, Phase 3 study of diroximel fumarate, an investigational, novel oral fumarate with a distinct chemical structure, for relapsing-remitting multiple sclerosis (RRMS), compared …

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Janssen’s Investigational Ponesimod Meets Primary and Most Secondary Endpoints in its Phase 3 Study in Relapsing Multiple Sclerosis

TITUSVILLE, N.J., July 25, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive top-line results from the Phase 3 OPTIMUM study, which evaluated the efficacy and safety of ponesimod compared to Aubagio®* (teriflunomide) in adults with relapsing multiple sclerosis. The study met its primary and …

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FDA Accepts Celgene’s Application for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review …

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New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis

CAMBRIDGE, Mass., May 30, 2019 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced today new interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that the investigational treatment diroximel fumarate was generally well tolerated in people with relapsing multiple sclerosis (MS). These results were presented at the annual meeting of the …

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