The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) filed by Vanda Pharmaceuticals for its drug tradipitant to treat gastroparesis.
The regulatory agency will give a decision on the approval on 18 September 2024 under the Prescription Drug User Fee Act.
Tradipitant is the first drug to be accepted for FDA review for gastroparesis in more than three decades and will become the first to receive approval in more than four decades.
The NDA filing comprises data from clinical efficacy trials 2301 and 3301, findings from a 12-week, open-label study and findings from an expanded access programme.
The safety database in the NDA is reviewed and comprises more than 1,000 patients with exposures of up to 12 weeks. It also has data from the expanded access programme with subject exposures of more than two years.
The company presented non-animal preclinical toxicology data derived from microphysiological systems. The data was accepted for review by the regulator in the absence of a nine-month toxicity study in dogs.
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An NK-1R antagonist, tradipitant was licensed by Vanda from Eli Lilly and Company.
Vanda Pharmaceuticals president, CEO and board chairman Mihael Polymeropoulos stated: “We are very pleased with the FDA’s acknowledgment of the completeness of our application and we look forward to a substantive review.
“Tradipitant, if approved, will be the first novel drug for patients with gastroparesis since 1979.
“We are also encouraged by the FDA’s decision to accept for filing this application that includes non-animal preclinical toxicity data from advanced human-relevant microphysiological systems in the absence of a nine-month dog study.”
The company previously filed two supplemental new drug applications for Hetlioz to treat insomnia and for Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder.
Decisions on approval of Hetlioz and Fanapt are anticipated in March and April 2024 respectively.