Evoke Pharma receives FDA review letter relating to Gimoti to treat gastroparesis

Evoke Pharma, Inc. announced the receipt of a multi-disciplinary review (DR) letter from the FDA in association with the Gimoti 505(b)(2) New Drug Application (NDA). A DR letter is used by the FDA to convey preliminary thoughts on deficiencies identified during the initial stage of NDA review.

The letter described concerns in three sections of the NDA: Chemistry (combination product quality control and reproducibility specific to the commercially available sprayer device used with Gimoti); Clinical (lack of adequate information to support sex-based efficacy differences); and Clinical Pharmacology (maximum concentration (Cmax) not within the parameters for bioequivalence for abbreviated NDAs).

Although a DR letter reflects preliminary comments that are subject to change and does not reflect a final FDA decision on the NDA, approval of Gimoti by the PDUFA date of April 1, 2019 is uncertain given the letter. The Company plans to respond to the deficiencies raised in the DR letter to allow time for potential FDA review prior to the PDUFA date.