Vanda Pharmaceuticals Challenges FDA Rejection of Tradipitant for Gastroparesis, Accepts Hearing Opportunity

Vanda Pharmaceuticals has announced its acceptance of an FDA hearing opportunity to address the rejection of its New Drug Application (NDA) for tradipitant, a neurokinin 1 receptor antagonist, proposed for treating gastroparesis. The FDA issued a Complete Response Letter in 2024, citing insufficient evidence of efficacy despite acknowledging statistically significant results in one study. Vanda argues that the FDA's additional requirements for "clinically meaningful" results and two-study validation deviate from the "substantial evidence" threshold set by Congress, potentially preventing the approval of effective therapies for unmet needs.

The company highlights the severe challenges of studying gastroparesis due to high placebo responses and patient recruitment difficulties, emphasizing the promising data from multiple studies and real-world cases where tradipitant showed sustained benefits. Despite the FDA's critiques, Vanda maintains that the evidence is sufficient to meet statutory approval criteria.