US FDA refuses to approve Vanda drug for stomach problems

(Reuters) – Vanda Pharmaceuticals said on Thursday that the U.S. Food and Drug Administration had rejected approval of its drug to treat a stomach disease with indigestion and called for further studies.

The company's shares fell about 14% to $4.26 in premarket trading.

Vanda sought approval of the drug tradipitant by the health authorities to treat the symptoms of gastroparesis, a condition characterized by delayed gastric emptying.

The disease is accompanied by symptoms such as severe nausea, vomiting and difficulty finishing a normal meal.

The decision is another setback for Vanda after the FDA rejected an expansion of the drug Hetlioz's approval to treat insomnia earlier this year.

In response to the FDA's rejection, the company said that the additional studies requested by the FDA were designed in a way that was “inconsistent with the recommendations of leading experts in the field” and that it would continue to pursue approval of the drug.

Vanda has repeatedly asked the FDA to convene a panel of experts to review the drug, but the agency has refused, it said.

Tradipitant, which Vanda licensed from Eli Lilly, failed to meet its primary goal of a change in nausea severity compared with placebo after 12 weeks in a late-stage study.

Vanda still needs to meet FDA requests for additional animal studies and long-term safety data, raising questions about whether the drug can be prescribed for chronic use, said Jefferies analyst Andrew Tsai.

The FDA had imposed a partial clinical halt on tradipitant for safety reasons, thereby preventing studies lasting longer than 12 weeks.

The drug is also being tested to prevent vomiting in motion sickness. A separate application is planned for later this year.

(Reporting by Sriparna Roy in Bengaluru; Editing by Abinaya Vijayaraghavan and Leroy Leo)