Drugs

FDA Denies Approval/Hearing on Vanda Stalled sNDA

FDA has refused to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) capsules, 20 milligrams (mg) for treating jet lag disorder. “Based on a review of the parties’ submissions, FDA finds that there is no genuine and substantial issue of fact justifying a hearing on CDER’s proposal to refuse to approve sNDA 205677-004,” a just-posted order from the agency says, adding that it is formally denying approval of the sNDA.

In deciding the hearing request and the sNDA’s fate, principal deputy commissioner Namandjé N. Bumpus’ final order says the company failed to provide “substantial evidence that tasimelteon is effective for the proposed indication of treatment of jet lag disorder. Among other deficiencies, Vanda did not demonstrate that the primary and secondary endpoints were appropriate for assessing the effect of tasimelteon for the treatment of jet lag disorder, and Vanda failed to prespecify a multiple testing procedure to control overall Type I error for any secondary efficacy endpoints.”

Bumpus also concludes that Vanda’s studies examined “limited aspects of tasimelteon’s effect on subjects’ sleep and reflect a flawed assessment of certain subjective measures related to other aspects of jet lag disorder.” She writes that in totality, the company’s studies “paint an incomplete picture and preclude a finding of substantial evidence of tasimelteon’s effectiveness in treating 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.”

Additionally, Bumpus says Vanda’s arguments requesting the hearing were not supported by “reliable evidence.” She further says the lack of evidence is “fatal to the application; there is no material issue of fact as to whether the application is approvable because the application lacks the basic evidence necessary to justify an FDA approval decision. The data and information submitted is conclusively inadequate on its face… Finally, the material facts of Vanda’s application are not in dispute; Vanda does not dispute any fact from which CDER draws inferences and conclusions about tasimelteon. Vanda instead disputes CDER’s inferences and conclusions. Such disputes do not justify a hearing.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome