The US Food and Drug Administration (FDA) has accepted for priority review Vanda Pharmaceuticals Inc’s applications for Smith-Magenis Syndrome (SMS). The applications include a Supplemental New Drug Application (sNDA) for melatonin receptor agonist HETLIOZ (tasimelteon) capsules and a New Drug Application (NDA) for the liquid formulation of HETLIOZ for the treatment of adults and children, respectively, with Smith-Magenis Syndrome (SMS).
HETLIOZ (tasimelteon) improved sleep quality and increased sleep duration in patients with Smith-Magenis Syndrome (SMS) in a placebo-controlled clinical study. HETLIOZ is currently approved for the treatment of Non-24-Hour Sleep-Wake Disorder.
The FDA has set December 1, 2020 as the target date for its decision on HETLIOZ for Smith-Magenis Syndrome under the Prescription Drug User Fee Act (PDUFA-VI).
“The FDA filing of the HETLIOZ applications for priority review marks a major milestone and brings us closer to providing a critical therapy to patients with SMS,” says Mihael H. Polymeropoulos, MD, Vanda’s President and CEO, in a release. Currently, there are no approved treatments for patients with SMS, a disorder affecting approximately 15,000 people in the United States.