The FDA has rejected Vanda Pharmaceuticals' marketing application for tradipitant, meant to treat gastroparesis.
Vanda received a Complete Response Letter (CRL) on September 18, 2024, indicating that the FDA found the evidence insufficient to approve the drug. Gastroparesis, a condition characterized by delayed gastric emptying, can cause symptoms like nausea, vomiting, and difficulty eating, with no new FDA-approved treatments in over 40 years.
The application included data from two placebo-controlled studies, additional exposure-response data, and real-world evidence from patients in an expanded access program. Despite this, the CRL requested additional studies, which Vanda argues are inconsistent with expert guidance and the current understanding of the condition. The company expressed frustration with the FDA's delay in response, which exceeded the statutory 180-day review period.
Vanda has now voiced its concerns over the FDA's decision, stating that tradipitant has demonstrated sufficient efficacy and a favorable benefit-risk profile for treating gastroparesis. The company has also requested that the FDA convene an expert advisory committee to review the drug, a request that has been denied. Patients currently receiving the drug have filed a Citizen Petition urging the FDA to reconsider its stance.
Despite the setback, Vanda plans to continue seeking marketing approval for tradipitant and will maintain its expanded access program for patients with gastroparesis. The company also plans to submit a new application for the use of tradipitant in preventing motion sickness later this year.