EMA accepts Otsuka’s marketing authorization application for tolvaptan

Otsuka Pharmaceutical Co., Ltd. announced in late December that the European Medicines Agency (EMA) has accepted the submission of a marketing authorization application (MAA) for the potential approval of tolvaptan for the treatment of ADPKD in Europe.

The EMA is the European version of the U.S. Food and Drug Administration (FDA) in the United States. An MAA is called a new drug application (NDA) in the U.S.

In the United States, Otsuka and FDA have been working together to determine the most appropriate path forward to allow tolvaptan to be available for patients suffering from ADPKD. In late August of 2013, Otsuka Pharmaceutical Development & Commercialization, Inc. received a Complete Response Letter (CRL) from the FDA regarding tolvaptan to treat adult patients with ADPKD. The FDA issues CRLs to convey that their initial review of an NDA is complete and they cannot approve it in its present form.

Read the official press release from Otsuka.