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European Medicines Agency Accepts Otsuka America Pharmaceutical, Inc.'s Marketing Authorisation Application (MAA) For Tolvaptan, An Investigational Compound For Autosomal Dominant Polycystic Kidney Disease (ADPKD)


12/27/2013 7:38:51 AM

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TOKYO--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. announced today that the European Medicines Agency (EMA) has accepted the submission of a marketing authorisation application (MAA) for the potential approval of tolvaptan for the treatment of autosomal dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New England Journal of Medicine.i

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