Evoke Pharma has finally won an FDA approval for the only drug in its pipeline.
Last year, a phase 3 study of the Gimoti, a nasal spray designed to relieve symptoms related to diabetic gastroparesis, showed it had missed its primary endpoint — but the drug still had a “meaningful benefit” for 51 percent of patients. The FDA, however had concerns related to the dosing stability created by a pump used for drug delivery. Ultimately, the agency issued a Complete Response Letter and stock for Evoke plunged.
In December, Evoke resubmitted its application with new data and has now finally won approval. Upon news of the FDA’s decision, Evoke’s stock shot up by 62 percent on Monday.
The company’s CEO said approval will provide diabetic patients with gastroparesis the first novel treatment for their symptoms in “several decades.”
