|Alexion Pharmaceuticals Inc., of Boston||Soliris (eculizumab)||C5 complement inhibitor||Neuromyelitis optica spectrum disorder||Japan’s Ministry of Health, Labour and Welfare approved extension of marketing authorization to include prevention of relapse in patients with AQP4 antibody-positive NMOSD, including neuromyelitis optica|
|Biomarin Pharmaceutical Inc., of San Rafael, Calif.||Valoctocogene roxaparvovec||Gene therapy||Severe hemophilia A||Submitted MAA to EMA; anticipates start of review to commence in January 2020 under accelerated assessment|
|SK Biopharmaceuticals Co. Ltd., of Pangyo, South Korea||Xcopri (cenobamate tablets)||Positive allosteric modulator of GABAA||Partial-onset seizures||Approved by FDA for use in adults|
|Sunovion Pharmaceuticals Inc., of Marlborough, Mass.||Apomorphine sublingual film (APL-130277)||Fast-acting version of dopamine agonist||Parkinson’s disease||Resubmitted NDA seeking approval to treat motor fluctuations (OFF episodes), in response to Jan. 29, 2019, complete response letter; resubmission included information about intended packaging as well as additional analyses of clinical data|
For more information about individual companies and/or products, see Cortellis.