Vanda Pharmaceuticals Inc. (VNDA), a biopharmaceutical company announced on Monday, that it has accepted the FDA's offer for a hearing regarding its New Drug Application or NDA for tradipitant, a neurokinin 1 receptor antagonist aimed at treating gastroparesis. The FDA issued a Complete Response Letter in September 2024, rejecting the application due to insufficient evidence of efficacy.
Vanda disagreed with this decision and has now requested the hearing as part of its efforts to address the FDA's concerns and present additional supporting evidence.
Gastroparesis is a serious and often debilitating digestive disorder, and no new drug has been approved for its treatment in over 40 years.
Vanda's development of tradipitant has involved over a thousand patients, including an expanded access program, with positive results.
Two pivotal studies were conducted: Study 1 showed a significant improvement in nausea severity, while Study 2 had more mixed results, according to the company. Vanda believes that additional exploratory analyses and data from a large open-label study support tradipitant's efficacy, but the FDA discounted these findings.
Vanda criticized the FDA's interpretation of the data, arguing that the agency has set an excessively high standard for approval, one that is not aligned with statutory requirements.
Vanda also emphasized the substantial unmet medical need for new treatments in gastroparesis, especially as current therapies are often ineffective or poorly tolerated.
Vanda hopes the FDA will adhere to the statutorily mandated timeframe for the hearing, which must take place within 120 days of the Notice of Opportunity for Hearing or NOOH.
VNDA closed Friday's (Jan.24, 2025) trading at $4.40 down 0.45%. In premarket trading Monday, the stock is up 2.27% at $4.50.
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