The U.S. FDA declined to approve Vanda Pharmaceuticals’ New Drug Application for tradipitant for the treatment of symptoms in gastroparesis, handing Vanda a complete response letter.
The approval, which had a September 18 PDUFA date, would have marked the first effective treatment approved by the FDA for gastroparesis in over 40 years. Gastroparesis, or stomach paralysis, is a condition that is characterized by delayed gastric emptying and associated with severe nausea, vomiting and difficulty finishing a normal meal.
Vanda — pointing out that its tradipitant application included evidence from two placebo-controlled studies and that evidence of efficacy was further supported by exposure response data from a large open label study as well as the real-world experience from expanded access programs — took issue with the CRL.
“The CRL 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,” the company said in a press release.
Calling the agency’s action “disappointing,” Vanda also pointed out that the FDA’s decision was delayed by more than 185 days, thus failing to satisfy the requirements specified by the Food Drug and Cosmetic Act. According to the drugmaker, the FAD refused to convene an advisory committee to review the tradipitant application.
Vanda picked up the global development rights to tradipitant, a neurokinin-1 (NK1) receptor antagonist, from Eli Lilly in 2012. Under the terms of the deal, Vanda paid an initial $1 million, with Lilly eligible to receive additional payments up to $99 million based upon achievement of specified development and commercialization milestones.
Going forward, Vanda says it will continue to pursue the marketing authorization for tradipitant and will continue to support its expanded access program. The company also plans to submit a separate NDA for tradipitant for the prevention of vomiting in motion sickness later this year.