Praxis Precision Medicines Secures US FDA Priority Review for Epilepsy Drug Application

MT Newswires Live

03/31

Praxis Precision Medicines (PRAX) said Monday the US Food and Drug Administration accepted its priority review new drug application for relutrigine to treat developmental and epileptic encephalopathies.

The regulatory agency established a decision deadline of Sept. 27 for the medication, which is backed by favorable data from the EMBOLD trial that concluded prematurely due to demonstrated efficacy, the company said.

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