Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation.
Vanda Pharmaceuticals has filed another lawsuit against the U.S. Food and Drug Administration after failing to win a legal victory against the regulatory agency two years ago when it challenged a clinical hold levied against tradipitant, its experimental treatment for gastroparesis.
Now, Washington, D.C.-based Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation. The FDA rejected the bid based on the grounds that tradipant didn’t have “the potential to address an unmet medical need,” Law360 reported.
However, the complaint alleges that the FDA did not deny that gastroparesis is life-threatening and there are patients with an unmet medical need. Gastroparesis is a chronic gastrointestinal disease that causes the stomach to have an inability to empty itself in normal manners. Symptoms of the disease are heartburn, nausea and vomiting. Tradipant has shown efficacy against nausea, the company said. Treatment options are limited to a 40-year-old drug or surgery.
Tradipitant is a neurokinin-1 (NK-1) receptor antagonist under development for the treatment of idiopathic and diabetic gastroparesis. Earlier this year, tradipitant failed to hit endpoints in a Phase III study assessing the drug’s ability to treat the symptoms of gastroparesis. The company said tradipitant did not distinguish itself against placebo on the change of severity of nausea from baseline after 12 weeks of treatment. Vanda stressed in its announcement that both treatment arms showed significant improvements from baseline on nausea as well as the other core symptoms of gastroparesis.
In previous clinical studies, tradipitant met its primary endpoint in patients with idiopathic and diabetic gastroparesis. The company also said tradipitant was well tolerated with comparable rates of adverse events between the tradipitant and placebo groups. Vanda said an analysis of the Phase III study found some “potential confounders that may have masked the beneficial effect of the drug previously observed in the Phase II study of tradipitant,” which included a baseline imbalance of rescue medication use. There was also poor compliance observed in some patients, the company said.
In its lawsuit, Vanda claims the FDA has “essentially rewritten the statute” regarding Fast Track designation in order to discount tradipitant’s “demonstrated ‘potential to address unmet medical needs,” Law360 reported.
“Indeed, rather than consider the existing evidence supporting tradipitant’s potential to fill the unmet needs of gastroparesis patients - as required by statute - FDA rested its rejection of Vanda’s Fast Track application on its own beliefs about what data Vanda may or may not collect as part of its ongoing development program, and whether those data may satisfy the criteria for ultimate marketing approval,” the company said, according to the complaint.
The lawsuit against the FDA is just the latest of a number of legal filings against the regulatory agency made by Vanda. Law360 noted that earlier this year, Vanda filed a lawsuit against the FDA seeking an explanation as to why the agency denied a label expansion on the company’s sleep-wake disorder drug Hetlioz. That lawsuit remains pending, Law360 reported.
In February 2020, Vanda filed a lawsuit after the FDA placed a partial clinical hold on tradipitant. The regulator had requested that Vanda conduct a nine-month toxicity study in animals before in-human studies could continue. As BioSpace reported at the time, Vanda rejected the request, arguing that additional animal studies beyond what had already been completed would be “unnecessary and unethical.”
