Vanda Pharmaceuticals Receives FDA Rejection for Gastroparesis Treatment, Criticizes Agency’s Decision

FDA Rejection:
The FDA declined to approve Vanda Pharmaceuticals' New Drug Application (NDA) for tradipitant, a treatment for gastroparesis, on September 18, 2024.

Reason for Rejection:
The FDA's Complete Response Letter (CRL) was described as "conclusory" and suggested that Vanda conduct additional studies, despite the company providing evidence from two placebo-controlled studies and an open-label study.

Vanda's Response:
Vanda issued a fiery response criticizing the FDA's decision, stating that the agency failed to satisfy the requirements specified by the Food Drug and Cosmetic Act (FDCA) by delaying the review beyond 180 days.

Impact:
Gastroparesis is a serious condition with no effective FDA-approved treatment in over 40 years, affecting patients with severe nausea, vomiting, and difficulty finishing meals.

Future Plans:
Vanda plans to continue pursuing marketing authorization for tradipitant and will submit a separate NDA for the prevention of vomiting in motion sickness later this year.