Vanda slips as FDA rejects therapy for stomach condition

Vanda Pharmaceuticals (NASDAQ:VNDA) fell ~9% in the premarket on Thursday after the U.S. FDA declined to approve its marketing application for experimental therapy, tradipitant for a stomach-related medical condition called gastroparesis.

Issuing a Complete Response Letter (CRL) regarding Vanda’s (VNDA) New Drug Application (NDA) on Wednesday, the agency suggested the company conduct additional studies.

A condition characterized by delayed gastric emptying, gastroparesis has also recently been associated with the popular GLP-1 class of weight loss drugs, such as those developed by Eli Lilly (LLY) and Novo Nordisk (NVO).

Vanda (VNDA) criticized the FDA after the rejection, noting that the agency’s decision was not in compliance with the Food Drug and Cosmetic Act (FDCA) as it was delayed by more than 185 days.

“The FDCA requires that the FDA review a new drug application and, within 180 days of submission, provide either an approval or an opportunity for a hearing. In this case, the FDA failed to do either,” the company said.

Vanda (VNDA) also noted that despite its repeated requests, the FDA declined to conduct an AdCom meeting before making the decision.

The Washington, DC-based firm expects to file a separate NDA for precipitant later this year, targeting the prevention of vomiting in motion sickness.