Catalyst Pharma Says FIRDAPSE NDA Submitted In Japan By Partner DyDo Pharma

(RTTNews) - Biopharmaceutical company Catalyst Pharmaceuticals, Inc. (CPRX) announced Monday that its collaboration partner, Japan's DyDo Pharma, Inc., reported that it has submitted a New Drug Application (NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, seeking marketing approval for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in Japan.

The submission is based on preliminary favorable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of FIRDAPSE for the treatment of LEMS.

The review period is expected to be approximately a minimum of nine months from the submission date.

In June 2021, Catalyst entered into a license agreement with DyDo for the development and commercialization of FIRDAPSE in Japan.