Bengaluru: Vanda Pharmaceuticals said on Thursday the U.S. Food and Drug Administration declined to approve its drug to treat a type of stomach condition that disrupts digestion and called for additional studies.
Shares of the company fell about 14 per cent to $4.26 in premarket trading.
Vanda was seeking the health regulator’s nod for the drug, tradipitant, to treat symptoms of gastroparesis, a condition characterized by delayed gastric emptying.
The disease is associated with symptoms such as severe nausea, vomiting, and difficulty finishing a normal meal.
The decision comes as another setback for Vanda after the FDA declined to expand the approval of its drug Hetlioz to treat insomnia earlier this year.
In response to FDA’s rejection, the company said the additional studies required by the FDA had a design that was “inconsistent with the advice of key experts in the field”, adding that it will continue to pursue the drug’s approval.
Vanda has repeatedly requested the FDA to convene a panel meeting of experts to review the drug, but the regulator has refused to do so, it said.
Tradipitant, which Vanda licensed from Eli Lilly, failed to meet the main goal of change in the severity of nausea, compared to placebo, at 12 weeks in a late-stage trial.
Vanda still needs to meet the FDA’s request for additional animal studies and long-term safety data, raising the question if the drug can be prescribed for chronic use, Jefferies analyst Andrew Tsai said.
The FDA had imposed a partial clinical hold on tradipitant, preventing trials longer than 12 weeks due to safety concerns.
It is also studying the drug to prevent vomiting during motion sickness and plans to submit a separate application for it later this year. (Reporting by Sriparna Roy in Bengaluru; Editing by Abinaya Vijayaraghavan and Leroy Leo)
