Drugs

Vanda Hits FDA for Rejecting Tradipitant

Vanda Pharmaceuticals is criticizing FDA for failing to approve the company’s NDA for tradipitant to treat the symptoms of gastroparesis. A company statement says FDA issued a complete response letter that “was conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder. Furthermore, FDA’s action was delayed by more than 185 days and fails to satisfy the requirements specified by the Federal Food, Drug, and Cosmetic Act.”

The statement says the NDA was supported by two studies that have been published in peer-reviewed journals and by exposure-response data from a large open-label study as well as the real-world experience of dozens of patients treated in an expanded access program, some for several years. It says FDA has not approved an effective gastroparesis treatment in over 40 years.

Vanda says FDA has rejected its requests that it take the NDA to an advisory committee for review and recommendations.

“Despite the disappointing action by FDA,” the statement concludes, “Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard with a favorable benefit/risk profile for the treatment of patients with gastroparesis….Vanda will continue to pursue the marketing authorization for tradipitant and will continue to support the expanded access program that is currently serving several dozen patients with gastroparesis…. Vanda plans to submit a separate NDA for tradipitant for the prevention of vomiting in motion sickness later this year.”

For several months this year, Vanda has been fighting with FDA over the fate of an sNDA for its Hetlioz (tasimelteon), which is currently indicated to treat non-24-hour sleep-wake disorder and night-time sleep disturbances in Smith-Magenis Syndrome patients. In June the agency posted a notice indicating it planned to deny the sNDA.

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