Proposal to Refuse to Approve a New Drug Application for TRADIPITANT; Opportunity for a Hearing
Published Date: 1/16/2025
Notice
Summary
The FDA is thinking about saying no to Vanda Pharmaceuticals' new drug, TRADIPITANT, in its current form. Vanda can ask for a hearing to explain why the drug should be approved. If you want to speak up or support the hearing, you’ve got until mid-February and mid-March 2025 to send in your requests and info.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
FDA Identifies Major Data Gaps
FDA identified specific deficiencies in the submitted clinical and nonclinical data: Study 3301, Group 1 failed to show statistically significant efficacy versus placebo; Study 2301 had methodological shortcomings; post hoc analyses are insufficient; clinical safety data are limited to 12 weeks; and nonclinical studies did not adequately characterize long-term safety. FDA recommended Vanda conduct two new adequate and well-controlled trials in adults with idiopathic or diabetic gastroparesis and a chronic repeat-dose toxicity study in a nonrodent species to address these deficiencies.
FDA Proposes Refusal of TRADIPITANT
The FDA proposes to refuse approval of Vanda Pharmaceuticals' new drug application (NDA 218489) for TRADIPITANT capsules, 85 mg, in its present form because the agency found the application does not provide substantial evidence of effectiveness and does not demonstrate safety for the proposed use. If no timely hearing request is filed, FDA will issue a notice refusing to approve the application.
Hearing Opportunity and Deadlines
Vanda and other interested persons may request a hearing on FDA's proposal; hearing requests must be submitted by February 18, 2025, and supporting data, analyses, or other comments must be submitted by March 17, 2025. The notice warns that failure to request a hearing in the required manner and time will waive the opportunity and FDA will issue a refusal to approve the application.
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