Vanda Pharmaceuticals’ seven-year ambition to expand the label for its sleeping drug Hetrios took an unusual turn when the FDA acquiesced in a formal hearing on the matter.
The evidentiary hearing arrangement comes after the agency rejected Vanda’s proposal to expand Hetrios’ jet lag label for the second time in January, citing concerns that the company’s clinical trial protocols were “not sufficiently similar to actual jet travel,” according to Vanda’s explanation for the rejection.
Banda disagreed with that assessment, vowing to consider “all appropriate avenues” to pursue its long-sought jet lag symptoms and arguing that the decision does not fully reflect the “spirit of cooperation” the two sides established in October, when Banda agreed to put the brakes on aggressive litigation against the FDA in exchange for regulatory action.
The company has been fighting hearings ever since the FDA first rejected its jet lag claim in 2019, eventually taking the issue to court in 2022.
Now, Vanda’s wish for a public hearing is being fulfilled, the company said in a March 3 press release.
“We are encouraged by the FDA’s decision to grant a formal evidentiary hearing on the proposed denial of the jet lag application to Hetrios,” Vanda CEO Michael H. Polymeropoulos, MD, said in a release. “This procedural victory reflects Mr. Vanda’s seven years of tenacity in advocating for fairness and the rigorous pursuit of scientific truth on behalf of patients.”
Formal evidentiary hearings on complete responses are permitted under the U.S. Code of Federal Regulations, but have not been held in the drug regulatory context for decades, “perhaps more than 40 years,” Banda said, citing “public records and historical accounts.”
The door to the hearing opened last summer when a federal appeals court sided with Banda, calling it a “landmark victory” as the company seeks transparency behind the FDA’s rejection.
The ruling specifically supported Vanda’s previous legal victory in 2024, when a D.C. court ordered the FDA to resolve Hetrios’ pending drug application or hold a hearing, given that the company’s application had been pending for “nearly 2,000 days” at the time and more than 500 days had passed since the company’s request for a hearing.
At the time, the FDA issued an order denying approval of the jet lag symptoms in exchange for granting a public hearing. A 2025 appeals court victory vacated the order and sent the ball back to the FDA’s court, which Banda expected would lead to approval or a formal hearing.
During its seven-year dispute with the FDA, the company never spoke about its concerns over, as it said in 2024, “serious deficiencies in the FDA regulations governing the drug approval process.” Mr. Banda also sued the FDA on other issues related to Hetrios.
Despite the Hetrios holdup, the company recently scored two other regulatory victories with the approval of motion sickness drug Nereus and atypical antipsychotic Visanti.
Meanwhile, Hetrios was first approved for the treatment of non-24-hour sleep-wake disorder in 2014, and was subsequently approved for the treatment of Smith-Magenis syndrome in 2020.
