US regulator does not approve novel Parkinson's drug, calls for more data

31 January 2019

US-based Sunovion Pharmaceuticals has been rejected in its bid for approval for apomorphine sublingual film (APL-130277), receiving a Complete Response Letter from the US regulator.

The news comes as a second blow in as many days for parent company Sumitomo Dainippon (TYO: 4506), which faced a trial setback on Wednesday related to its cell and gene therapy program. Shares in the firm are down around a fifth at close of trading in Tokyo.

Sunovion applied under the US Food and Drug Administration’s fast track program, after receiving positive Phase III data at the start of 2018.

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