Vanda Pharmaceuticals Inc received a complete response letter (CRL) from the US Food and Drug Administration (FDA) on Aug 16 as part of the FDA’s ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) for the treatment of jet lag disorder (JLD).
As Vanda previously reported on May 23, 2018, JLD patients reported sleeping nearly 3 hours longer over the 3 nights following their transatlantic trip when treated with Hetlioz than they did over the 3 nights following their untreated transatlantic trip, consistent with Vanda’s jet lag simulation studies. In the response letter, the FDA stated these measures demonstrating improved sleep are of unclear clinical significance.
In a release, Vanda states it is “perplexed by this conclusion, given that millions of travelers who experience JLD every year recognize that JLD is characterized by disruption of nighttime sleep and/or sleepiness during the day due to rapid travel across time zones….
“JLD sufferers attempt to treat the condition with unapproved remedies, which do not address either the symptoms or the underlying cause of JLD. Additionally, these treatments are replete with potentially dangerous side effects when used. To date, there are no treatments approved by the FDA for JLD, a public health issue experienced by millions of people every year.”
The FDA response letter also 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,” says Mihael H. Polymeropoulos, MD, Vanda’s president and CEO, in a release. “Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need.”