Vanda Pharmaceuticals Inc received a notification from the US Food and Drug Administration (FDA) on July 19 stating that as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) for the treatment of jet lag disorder, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in this notification, and the FDA stated that this notification does not reflect a final decision on the information under review. In a letter dated December 19, 2018, the FDA had assigned a Prescription Drug User Fee Act (PDUFA) target date for completion of its review by August 16, 2019.
Vanda states that it has extensively studied the efficacy of the circadian regulator Hetlioz on jet leg disorder, which occurs following rapid eastward transmeridian travel and can result in significant and impairing symptoms.
Hetlioz was shown to be well tolerated prior to its first approval by the FDA in 2014. Since its commercial launch in 2014, thousands of patients with Non-24-Hour Sleep-Wake Disorder have been exposed to Hetlioz, many for periods of several years and on a daily basis.
In addition, Vanda has studied Hetlioz for almost 15 years in different settings and conditions and says Hetlioz has consistently demonstrated robust biological effects and clinical benefits.
Vanda anticipates receiving additional communication from the FDA identifying specific deficiencies in the sNDA. Vanda hopes that it will be able to work expeditiously with the FDA to resolve any such deficiencies.