Drugs

FDA Proposes to Deny Hetlioz sNDA

CDER says it is proposing to refuse to approve a Vanda Pharmaceuticals sNDA for a new indication for its Hetlioz (tasimelteon). A Federal Register notice says Hetlioz is currently indicated to treat non-24-hour sleep-wake disorder. Vanda is seeking a new indication for treating jet lag disorder.

The notice summarizes the deficiencies described in an 8/16/2019 complete response letter indicating why the sNDA could not be approved in its present form. The deficiencies were:

inadequate justification for primary endpoints in two clinical trials;
the clinical trials did not prespecify Type 1 error control for subjective endpoints;
the two studies each focused on only one jet lag-related symptom and one direction of travel in healthy subjects;
the studies did not include sufficient data to determine each individual’s reaction to the sleep advance within the protocol or the effects of the drug;
inadequate data to demonstrate the effectiveness of the drug when administered according to the dosing and administration information;
inadequate data to inform a recommendation on an optimal night to dose the drug and whether dosing on multiple nights is more effective than dosing on a single night;
inadequate data to characterize the use of the study drug with a sleep-delay cycle; and
the assessment of next-day functioning appears to use a scale that is not fit for purpose for the proposed indication.

“These deficiencies preclude a finding of substantial evidence of effectiveness for the treatment of jet lag disorder,” the notice says. “The complete response letter stated that to address the deficiencies Vanda should conduct at least one additional adequate and well-controlled study.”

Vanda submitted two formal dispute resolution requests that were denied by FDA. On 7/1 the company submitted a request for an opportunity for a hearing on whether there are grounds for denying approval of the sNDA.

The notice says that as part of its proposal to refuse to approve the sNDA, Vanda may request a hearing before the FDA commissioner on CDER’s proposal to refuse to approve the sNDA.

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