Vanda Pharmaceuticals is making a name for itself, at least when it comes to FDA lawsuits.
The DC-based company filed its latest complaint against the agency on Monday, with the company expressing concern over the FDA’s failure to grant expedited designation for Vanda’s potential tradipitant for chronic digestive disorders, which is an antagonist of neurokinin 1 receptors.
Specifically, Vanda said the FDA’s “essential point” in its one-page denial letter on designation pointed to “the lack of necessary safety data” which was “inconsistent with the criteria for … designation. FastTrack”.
But Vanda says tradipitant, which hopes to treat short-term nausea in patients with gastroparesis, “has been studied extensively in animals and humans for multiple indications, as of 2003. No human safety signals relevant has emerged”.
In December 2018, however, the FDA imposed a partial clinical hold on tradipitant, barring Vanda from studying the drug in humans for more than 3 months until the company could conduct a 9-month toxicity study in humans. non-rodent animals (dogs, monkeys or pigs).
“Vanda declined to conduct such a study,” the company said in its lawsuit. “Long-term toxicity studies always conclude with the death of the dogs tested, generally young beagles. And it would have diverted Vanda’s limited resources from drug research and development efforts to unnecessary animal testing.
And although the FDA has cleared a path for Vanda to move forward, the agency stated in its expedited denial letter that, based on the current tradipitious development plan as the FDA understood it, ” Vanda may not be able to obtain safety and efficacy data to obtain marketing approval.
Vanda’s decision to sue the FDA may seem like an odd move, but the company has sued the agency multiple times and recently lost at least one case regarding this FDA clinical hold on tradipitant.
The FDA issued the suspension after concluding that “existing studies of tradipitants in non-rodents contain enough troubling indications of toxicity such that – although short-term human studies may be safe enough to continue – the FDA must see if these markers of toxicity increase during long-term non-rodent studies before allowing long-term human studies.
Vanda Pharmaceuticals also took the agency to the same DC District Court again in April, alleging this time that the agency wrongly withheld parts of a rejection letter for a new indication for its sleeping pill Hetlioz (tasimelteon) for jet lag.
Sales of melatonin receptor agonist Hetlioz, approved in 2020 for non-24-hour sleep-wake disorders and nocturnal sleep disorders in Smith-Magenis syndrome, increased by $12.9 million , or 8%, to $173.5 million in 2021, from $160.7 million. million for 2020.