FDA Decision Due on Vanda Pharma's Gastroparesis Drug

By Colin Kellaher

A Food and Drug Administration decision is due this week on a proposed drug from Vanda Pharmaceuticals to treat gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying.

The FDA in December 2023 accepted Vanda's application seeking approval of tradipitant for the treatment of symptoms of the digestive condition, and the agency set a target action date of Sept. 18.

Vanda has previously said that an FDA green light would make tradipitant the first novel drug approved by the agency in more than four decades for gastroparesis, but in its second-quarter financial report in late July, Vanda disclosed that the FDA had provided a preliminary notice that deficiencies were precluding the discussion of labeling.

Vanda in April 2012 inked a license agreement with Eli Lilly to develop and commercialize tradipitant for all human indications. Eli Lilly is due a $10 million milestone for the first U.S. approval for tradipitant.

Vanda earlier this year reported positive results from a second Phase 3 study of tradipitant for the treatment of motion sickness and said it planned to file for FDA approval by the end of the year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 18, 2024 06:58 ET (10:58 GMT)

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