The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…
Priority review
MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease. MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential…
Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…
PathMaker Neurosystems Inc., a clinical-stage neuromodulation company focused on non-invasive therapies for neuromotor disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted the company’s MyoRegulator™ PM-2200 system the Expedited Access Pathway (EAP) designation and priority processing status. The MyoRegulator is the first product of PathMaker…
Ipsen Biopharmaceuticals, Inc announced that the United States Food and Drug Administration (FDA) has agreed to review the supplemental Biologics License Application (sBLA) for Dysport® (abobotulinumtoxinA) to treat upper limb spasticity, a condition that affects many people in the United States, including multiple sclerosis (MS)…
The UK’s National Institute for Health and Care Excellence (NICE) gave a positive final appraisal determination to the use of the Biogen Idec‘s drug Tecfidera (dimethyl fumarate) in adults for the treatment of relapsing-remitting multiple sclerosis (RRMS), having turned back on their preliminary negative recommendation. The oral…