Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation
Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.
The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.
Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”
But Vanda says that tradipitant, which it’s hoping to treat short-term nausea in gastroparesis patients, “has been studied extensively in animals and humans for multiple indications, beginning in 2003. No relevant human safety signals have emerged.”
In December 2018, however, FDA imposed a partial clinical hold on tradipitant, preventing Vanda from studying the drug in humans for longer than 3 months until the company could conduct a 9-month toxicity study in 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 in the killing of the test-subject dogs, typically young beagles. And it would have diverted Vanda’s limited resources from drug research and development efforts to unhelpful animal tests.”
And while the FDA paved somewhat of a path for Vanda to move forward, the agency said in its fast-track denial letter that based on the current tradipitant development plan as FDA understood it, “Vanda might not be able to obtain safety and efficacy data to achieve marketing approval.”
Vanda’s decision to sue the FDA might seem like an odd move, but the company has sued the agency multiple times and lost at least one case recently concerning that clinical hold from FDA on tradipitant.
The FDA issued the hold after concluding that “existing tradipitant studies in nonrodents contain sufficient troubling indications of toxicity such that—while shorter-term human studies may be safe enough to proceed—FDA needs to see if those toxicity markers increase during long-term nonrodent studies before allowing long-term human studies.”
Vanda Pharmaceuticals also the agency again in the same DC district court in April, alleging this time that the agency is wrongfully withholding parts of a rejection letter for a new indication for its sleep drug Hetlioz (tasimelteon) for jet lag.
Sales of the company’s melatonin receptor agonist Hetlioz, approved in 2020 for non-24-hour sleep-wake disorder and nighttime sleep disturbances in Smith-Magenis syndrome, increased by $12.9 million, or 8%, to $173.5 million for 2021, compared to $160.7 million for 2020.