Evoke: New drug application accepted for review by FDA

Evoke Pharma announced that the company’s 505 new drug application, or NDA, for Gimoti, the company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis, has been accepted for review by the FDA. In its filing communication, FDA stated that the NDA received on June 1, is sufficiently complete to permit a substantive review and set a target goal date under the Prescription Drug User Fee Act, or PDUFA, of April 1, 2019. If approved, Gimoti will be the first new non-oral drug treatment option for diabetic gastroparesis in four decades. Additionally, the Day-74 letter did not indicate that FDA is planning to hold an advisory committee meeting to discuss the NDA. In a separate written communication, the agency responded to the NDA request for proprietary name review by conditionally accepting the proprietary brand name, Gimoti. This review and conditional acceptance validate that Gimoti is a proprietary name consistent with FDA’s goal of preventing medication errors and potential harm to the public associated with product misidentification or confusion.

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