FDA accepts Evoke Pharma NDA for Gimoti; PDUFA date April 1
The FDA has accepted for review Evoke Pharma’s (NASDAQ:EVOK) 505(b)(2) NDA for Gimoti, the company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
The FDA also set a target date under the Prescription Drug User Fee Act (PDUFA) of April 1, 2019. If approved, Gimoti would be the first new non-oral drug treatment option for diabetic gastroparesis in four decades.
“We believe that Gimoti holds the potential to significantly improve the quality of life for these patients, particularly those who fail to achieve adequate relief from current oral therapy, and often face debilitating symptom flares of nausea, vomiting and abdominal pain,” Dave Gonyer, president and CEO of Evoke, said in a statement.
Mr. Gonyer also said the FDA letter did not indicate that the agency is planning to hold an advisory committee meeting to discuss the NDA. The FDA also conditionally accepted the Gimoti brand name.