Vanda Pushes Back on Hetlioz sNDA Hearing Denial

Vanda Pharmaceuticals is pushing back on a proposed order drafted by CDER in which FDA commissioner Robert Califf would refuse to either grant summary judgment to the company and approve its sNDA for a new indication for Hetlioz (tasimelteon) to treat jet lag disorder or hold a hearing on the issue.

In a sharply worded response, Vanda says the CDER proposed order “is a textbook example of unlawful agency action, both in process and substance, and the commissioner should decline to adopt it.”

Vanda insists that its clinical studies and other confirmatory evidence establish beyond dispute that Hetlioz is safe and effective in treating jet lag disorder. It says that CDER’s refusal to hold a hearing based on the fact that the company and Center agree on the numeric results of the clinical studies goes against Congress’ mandate that FDA can either approve an application or, on the applicant’s request, commence a hearing.

“Vanda’s evidence more than justifies approving Hetlioz for jet lag disorder,” the response says. “CDER’s many objections, which only critique aspects of the design of Vanda’s clinical studies for this novel indication, rather than their remarkable results, do not change that.”

The company also says that throughout the process, “CDER has repeatedly stonewalled Vanda’s good faith efforts to arrive at a scientifically sound resolution of this matter. Rather than engage with Vanda’s substantive evidence, CDER attempts to disregard Vanda’s hundreds of pages of material through the conclusory assertion that Vanda has not put forward ‘specifically identified reliable evidence.’ CDER claims that Vanda’s arguments are objections to matters of ‘scientific policy’ or ‘regulatory judgment,’ when Vanda has explained in excruciating detail in its opening submission … how CDER is disregarding critical facts and how CDER is failing to apply those well-established facts to the settled legal framework.”

The CDER proposed order denying the request for a hearing or summary judgment says Hetlioz was approved on 1/31/2014 to treat non-24-hour sleep-wake disorder. The company submitted its sNDA on 10/16/2018 seeking the indication to treat jet lag disorder.

In a 10/11/2022 notice, CDER summarized eight deficiencies it had listed in an 8/16/2019 complete response letter to explain why the sNDA could not be approved. Vanda submitted two formal dispute resolution requests that were denied by FDA and then sought the hearing.

The CDER proposed order has Califf saying the sNDA and subsequent submissions relating to Vanda’s hearing request “do not provide substantial evidence that tasimelteon is effective for the proposed indication of treatment of jet lag disorder…. Further, there is not a genuine and substantial issue of fact that would justify a hearing, and such a hearing would not otherwise be in the public interest. CDER and Vanda agree on the material facts at issue, including the numeric results of Vanda’s clinical studies. Even if any of Vanda’s contentions did raise a genuine and substantial issue of fact, they would not justify a hearing because, among other reasons, they are not supported by specifically identifiable reliable evidence, are not justified by sufficient data and information, or would not change the outcome if resolved in the way Vanda seeks.”