The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
Vanda Pharmaceuticals slammed what it called “FDA bureaucrats” who are “committed” to delaying the biotech’s request for a hearing regarding its gastroparesis drug candidate tradipitant.
What’s more, according to a statement released Wednesday by Vanda, these agency officials are shirking accountability and have instead pointed their fingers at “a new scapegoat,” namely the recent layoffs at the regulator and the newly appointed FDA Commissioner Marty Makary. “FDA bureaucrats have created policies to avoid scrutiny of their decision-making by habitually denying hearings,” Vanda continued.
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying. Patients with gastroparesis suffer from malnutrition, among other complications. Vanda said at the time that the regulator’s decision “generally disregarded” the data, while also criticizing what it called the FDA’s “delayed” action.
In January, the biotech escalated the matter to former FDA Commissioner Robert Califf. Vanda partly blamed Califf for cultivating and tolerating a “culture of obfuscation and closemindedness” at the agency. Days later, the FDA finally provided an explanation for the rejection: tradipitant “did not demonstrate a statistically significant” treatment effect, among other reasons, and gave Vanda the chance to have its case heard.
Vanda took the opportunity. Through its general counsel, the biotech told the FDA that it was expecting a hearing “no later than May 7.” But in a letter earlier this month, the FDA said that it would be able to respond to Vanda’s request “no later than September 12, 2025.” Among the reasons for the extended timeline include the “significant reduction in force” which affected certain officials that had been “assigned to lead the review” of Vanda’s request.
Vanda isn’t buying it. “This cannot be true,” the biotech said, noting Makary’s claims that the staffing cuts did not involve scientists or reviewers.
“It is unfair for CDER and its lawyers to blame the recent reductions in force for their habitual institutional delays on hearing requests,” according to Vanda. “These statements also conceal the extraordinary fact that FDA has denied every hearing request on new drug approvability for at least the past decade.”
In light of these issues, the biotech is asking Makary to “step in and restore adherence to the law at FDA.” It is yet unclear what specific actions Vanda is expecting from Makary.
BioSpace has reached out to Vanda for comment on the matter.
