The FDA flashed a red light on Vanda Pharmaceuticals’ experimental treatment for a gastrointestinal condition that disrupts the digestion process.
The agency rejected tradipitant in gastroparesis on Wednesday, the Washington-based company said Thursday morning. The biotech said it will keep seeking approval and will still support the expanded access program for the “several dozen patients” currently using that pathway.
Vanda offered a stinging rebuke of the agency’s actions, complaining that the FDA’s decision was delayed by more than 185 days and failed to “satisfy the requirements specified by the Food Drug and Cosmetic Act (FDCA).”
The company was also miffed that the regulator didn’t grant an advisory committee hearing, which Vanda wanted. The company submitted two placebo-controlled studies of part of its application package.
Signs did not seem to be pointing in Vanda’s favor after the company said in its second-quarter earnings update that “deficiencies” precluded the regulator from having discussions with Vanda about the drug’s label. The FDA told the company that its response then should not be considered a teaser of a decision on the full application.
“If you see it from the patient need, I think it is very important that tradipitant makes it to the armamentarium of drugs for gastroparesis,” CEO Mihael Polymeropoulos said. There has been “no effective treatment approved by the FDA in over 40 years” for the condition, the company added.
The latest rejection follows the FDA’s decision earlier this year not to tack on insomnia to the label of Vanda’s Hetlioz. The drug is approved to treat non-24-hour sleep-wake disorder and a rare behavioral condition called Smith-Magenis syndrome, but the FDA was dissatisfied by the package informing the insomnia ask.
Patients treated with tradipitant have filed a citizen petition with the FDA, requesting the agency approve it for gastroparesis, Vanda said Thursday.
The company added it will also submit a different NDA for the drug for vomiting prevention in motion sickness by year’s end.
Vanda’s stock price $VNDA dropped about 12% before the opening bell.