With a win in a D.C. appeals court, Vanda Pharmaceuticals has earned a point over the FDA in the yearslong face-off between the drugmaker and the drug regulator.
Vanda has been fighting to market its sleep disorder med Hetlioz for jet lag disorder since 2019, when the FDA first rebuffed the bid with a complete response letter (CRL). The company unsuccessfully attempted to dispute the rejection and eventually took the FDA to court after the agency delayed requests for a hearing on the matter.
Under the Food, Drug and Cosmetic Act, the FDA must allow drug manufacturers an opportunity for a hearing within 180 days of a new drug application. In 2024, a D.C. court sided with Vanda, ruling that the FDA must resolve the drug application or hold a hearing, considering that the application had been pending for “almost 2,000 days” at the time with over 500 days since the company’s most recent hearing request.
Instead of a hearing, the FDA issued an order refusing to approve the jet lag indication. Vanda then brought the matter to the U.S. Court of Appeals for the D.C. Circuit, arguing that the FDA had disregarded the “voluminous factual evidence” Vanda had provided.
Now, the appeals court has agreed with Vanda in a “sweeping win,” setting aside the FDA’s action, Vanda announced in a Monday release. The court determined that the FDA’s “treatment of Vanda's evidence is cursory” and that each of its trials of Hetlioz in jet lag disorder “showed statistically significant improvement on the primary endpoint measured."
The court decision throws the ball back in the FDA’s court, where Vanda expects the agency to approve the application or allow a hearing. The company “looks forward to further demonstrating that Hetlioz should be approved to treat jet lag disorder,” it said.
Vanda is no stranger to taking the FDA to court and has done so several times regarding both Hetlioz and other matters. With the latest win against the agency under its belt, the company suggests that other drug manufacturers can do the same.
“For too long, drug manufacturers failed to exercise their rights to lawful treatment by the FDA,” the company said in its release. “Vanda has demonstrated how courts can set aside illegal government actions that harm innovation and deprive Americans of important new therapeutics.”
To hear Vanda tell it, the decision “significantly alters the relationship between the FDA and the parties it regulates,” requiring the agency to “meaningfully engage” with evidence presented by drugmakers and not “shield its decisions via a plea for deference.”
Vanda is consistently outspoken about its gripes with the FDA, with the most recent feud outside of Hetlioz surrounding another CRL and subsequent hearing delay for its stomach disorder candidate tradipitant. The company slammed “FDA bureaucrats,” who, according to Vanda, have blamed the hearing delay on staffing cuts in the Center for Drug Evaluation and Research and presented “a new scapegoat” in new FDA Commissioner Marty Makary, M.D. The company sued the agency for the “unlawful delay” in April.
Hetlioz has been marketed for over a decade for non-24 hour sleep-wake disorder and won an expansion into nighttime sleep disorders associated with Smith-Magenis syndrome in 2020.