Drugs

Vanda Sues FDA to Overturn Fast Track Rejection

Vanda Pharmaceuticals is asking the DC federal court to set aside FDA’s denial of fast track status for the company’s tradipitant to treat gastroparesis and order the agency to reconsider Vanda’s application based on the statutory framework. The suit says the fast track designation is intended to facilitate the development and expedite the review of drugs that have the potential to address unmet medical needs for patients with a serious or life-threatening disease.

The company says the law covering fast track designation does not give FDA any discretion. If the statutory criteria are met, it says, FDA must grant the designation. The suit says the agency does not dispute that gastroparesis is a serious or life-threatening disease within the meaning of the law and it also does not dispute that patients with gastroparesis have unmet medical needs.

Vanda says FDA held that tradipitant supposedly does not demonstrate the potential to address an unmet medical need and in its one-page denial letter said the “lack of necessary safety data” was “inconsistent with the criteria … for fast track designation.”

Vanda says it requested a further explanation from FDA and still has not received any clarification or response.

The suit says the agency’s action is unlawful and must be set aside because:

it is based on an atextual view that Vanda must frontload its demonstration of satisfying the requirements for marketing approval to obtain fast track designation rather than demonstrating the potential for the drug to meet an unmet medical need as the law requires;
FDA arbitrarily treated tradipitant differently than other similar drugs for which it approved fast track designation, such as drugs intended to be used both for acute treatment and for a single symptom;
FDA reversed course from previous statements to Vanda that it saw a potential therapeutic role for the drug for the short-term relief of nausea in gastroparesis patients; and
FDA did not consider significant, relevant evidence before it that demonstrated tradipitant had the potential to provide short-term nausea relief in gastroparesis patients.

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