Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.

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