The US Food and Drug Administration (FDA) has declined to approve the new drug application (NDA) submitted by Vanda Pharmaceuticals for tradipitant to treat gastroparesis symptoms.
The decision was communicated through a complete response letter (CRL).
In December 2023, the FDA accepted a new drug application (NDA) seeking approval for the asset.
The application for tradipitant was supported by evidence from two placebo-controlled studies, bolstered by exposure response data from a large open-label study and the real-world experiences of patients in an expanded access programme.
However, the CRL dismisses the evidence and suggests further studies with a design and duration that Vanda believes to be inconsistent with expert advice and the scientific understanding of gastroparesis.
In a media release, Vanda Pharmaceuticals stated: “The FDA's action was delayed by more than 185 days and fails to satisfy the requirements specified by the Food Drug and Cosmetic Act (FDCA).
“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 added that the tradipitant NDA meets the evidence of efficacy standard and possesses a favourable benefit-risk profile for treating gastroparesis patients.
Multiple requests were made by the company to the FDA to convene an expert advisory committee to review the application, which the regulator declined.
In response to the decision, patients currently being treated with tradipitant have filed a citizen petition urging the agency to approve the treatment.
Despite the setback, Vanda is determined to continue pursuing marketing authorisation and support the ongoing expanded access programme serving several dozen gastroparesis patients.
Gastroparesis is a serious ailment marked by delayed gastric emptying, leading to severe nausea, vomiting and difficulty finishing meals, significantly impacting patients' daily lives.
The company plans to submit a separate NDA for tradipitant for preventing vomiting due to motion sickness towards the end of 2024.
