CDER Proposes to Deny Vanda Hetlioz sNDA

Federal Register notice: CDER is publishing a proposal to refuse the approval of a supplemental NDA submitted by Vanda Pharmaceuticals for Hetlioz (tasimelteon) capsules, 20 mg, indicated for treating insomnia characterized by difficulties with sleep initiation. The notice summarizes the grounds for not approving the supplement and offers Vanda an opportunity to request a hearing on the matter. According to CDER, Studies 3101 and 3107 are not adequate and well-controlled for insomnia disorder because the design excluded subjects with insomnia disorder, and scientific evidence was not provided to demonstrate that changes in healthy volunteers without insomnia disorder would correspond to a similar degree of response in patients with insomnia disorder. It also says the submission does not include adequate subjective, patient-reported data to demonstrate clinical benefit associated with the polysomnogram findings in Study 3104, among other issues. To view the notice, click here.