The European Commission approved Roche’s injectible drug Enspryng, which can be administered at home to treat neuromyelitis optica spectrum disorder.
Genentech presented new data on Enspryng (satralizumab-mwge), which was approved by the U.S. Food and Drug Administration in mid-August 2020 as a subcutaneous treatment for adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum.
Roche gets U.S. approval for Enspryng, takes on Alexion’s Soliris
Adults, Approvals, Blockbusters, Central Nervous System, Cytokines, FDA, FDA/Regulatory, Japan, Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder (NMOSD), Ophthalmology, Prescription Drug Costs, Rivalries, Spinal Cord, Therapeutics, United StatesThe U.S. Food and Drug Administration approved Roche’s Enspryng for the central nervous system disorder neuromyelitis optica, putting the Swiss drugmaker head-to-head with Alexion’s Soliris in a costly treatment area.
The U.S. Food and Drug Administration approved Viela Bio’s Uplizna (inebilizumab-cdon) for adults with neuromyelitis optica spectrum disorder who are anti-AQP4 antibody positive.
FDA Action Alert
Atopic Dermatitis (Eczema), Auto-Injection Therapy, B Cells, Biologics License Application (BLA), Complicated Urinary Tract Infections (cUTI), Diabetic Gastroparesis, Eosinophilic Asthma, FDA, FDA/Regulatory, Follicular Lymphoma, Inflammatory Diseases, Monoclonal Antibodies, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Pediatric Asthma, Prescription Drug User-Fee Act (PDUFA), Priority Review Status, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA)A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Genentech released full data from the company’s pivotal Phase III SAkuraStar trial of satralizumab as a monotherapy for NMOSD.
Top 10 Pipelines To Watch: 2019 Annual Report
Analysts, Ankylosing Spondylitis (AS), Annual Reports, Antiretroviral Drugs, Atopic Dermatitis (Eczema), Autoimmune Diseases, B Cells, Big Pharma, Biologics, Biopharma, Biotechnology, Blockbusters, BRCA Gene, BRCA mutation, Breakthrough Therapy Designation, Business, Cancer, CAR-T Therapy, Cells, Chemotherapy, Clinical Data, Clinical Trials, Collaborations, Crohn's Disease, Cystic Fibrosis, Drug Discovery, EU, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, February 2019, Future Blockbusters, Gene Editing, Generalized Myasthenia Gravis (gMG), Genomics, HIV, Human Genome, Immune Cells, Immune System, Immune-Mediated Diseases, Immunotherapy, Inflammatory Diseases, Injectables, Innovation, Integrase strand transfer inhibitors, Issue Archives, Japan, M&A, Med Ad News, Monoclonal Antibodies, Multiple myeloma, Neoantigens, Neurology, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Non-Small Cell Lung Cancer (NSCLC), Nonalcoholic Steatohepatitis (NASH), Nuclear Medicine, Oncology, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Precision Medicine, Prescription Drug User Fee Act (PDUFA), Priority Medicines (PRIME) Designation, Priority Review Voucher, Product Pipelines, Proteins, Psoriatic Arthritis, R&D, Radioligands, Rare Disorders, Research, Rheumatoid Arthritis, RNA Interference (RNAi), Sickle Cell Disease, Small Molecules, Special Reports, T-Cells, Top 10 Pipelines, Top 10 Pipelines To Watch, Tumors, Ulcerative Colitis, Ultra Rare DiseasesThe return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.