Posted by Michael Wonder on 03 Apr 2019
Evoke Pharma receives complete response letter and recommendations to address deficiencies from FDA for Gimoti NDA
2 April 2019 - Evoke Pharma today announced that it has received a complete response letter from the U.S. FDA for its 505(b)(2) new drug application for Gimoti for the relief of symptoms associated with acute and recurrent diabetic gastroparesis.
The letter, which cites fewer issues than the recent multidisciplinary review letter, states that FDA has determined it cannot approve the application in its present form and provides recommendations to address the two remaining approvability issues in a resubmission.
The issues are related to clinical pharmacology and product quality/device quality. The Agency did not request any new clinical data and did not raise any safety concerns.
