Vanda Pharmaceuticals "perplexed" by FDA rejection of jet lag drug
The FDA has issued a dreaded Complete Response Letter to Vanda Pharmaceuticals, rejecting the company’s jet lag drug Hetlioz (tasimelteon).
Washington DC-based Vanda said that the regulator had ruled that the measures used in trials to demonstrate improved sleep are of “unclear clinical significance”.
However the decision may not come as a complete surprise – the review was based on a tiny sample of only 25 patients, and the FDA last month highlighted deficiencies that prevented discussions about labelling and post-authorisation commitments.
The company last year announced results of the JET Study, a three-night transatlantic travel study on the effects of tasimelteon on Jet Lag Disorder (JLD).
At the time Vanda noted the small sample size, but noted that the drug succeeded in demonstrating “significant and meaningful effects” across a number of sleep and wake measures.
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 a statement Vanda said it is “perplexed” by the conclusion, noting that the American Academy of Sleep lists disturbed sleep and daytime sleepiness as essential features of Jet Lag Disorder.
The company added that jetlagged people may attempt to treat the condition with unapproved remedies, which do not address either the symptoms or underlying cause of jet lag.
Vanda's President and CEO Mihael Polymeropoulos said: “We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this programme.
“Vanda remains committed to obtaining FDA marketing approval for tasimelteon in Jet Lag Disorder in order to address this significant unmet medical need.”
Helioz was first approved by the FDA in 2014 as the first treatment for blind people who are experiencing a disrupted body clock and irregular sleep patterns.