Vanda Pharmaceuticals receives CRL from FDA on sNDA for HETLIOZ
Vanda Pharmaceuticals announced that on August 16, it received a Complete Response Letter from the U.S. FDA as part of its ongoing review of Vanda's supplemental New Drug Application for HETLIOZ for the treatment of Jet Lag Disorder. As Vanda previously reported on May 23, 2018, JLD patients reported sleeping nearly three hours longer over the three nights following their transatlantic trip when treated with Hetlioz than they did over the three nights following their untreated transatlantic trip, consistent with Vanda's jet lag simulation studies. In the CRL, the FDA asserted that these measures demonstrating improved sleep are of unclear clinical significance. The FDA's conclusions regarding the clinical significance of improved sleep in JLD are not the FDA's only observations made with respect to the sNDA. The CRL contains additional observations on various aspects of Vanda's sNDA. Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter. "We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program," said Mihael Polymeropoulos, M.D. Vanda's President and CEO. "Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need."