UPDATE 1-U.S. FDA declines to approve Vanda's stomach paralysis drug

Reuters
2024-09-19

(Adds shares in paragraph 2, details on disease in paragraph 3 and 4, background in paragraphs 5-7)

Sept 19 (Reuters) - The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals'

drug to treat stomach paralysis symptoms, the company said on Thursday.

Shares of the company fell about 14% to $4.26 in premarket trading.

Vanda was seeking the health regulator's nod for the drug tradipitant to treat 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.

Vanda licensed tradipitant from Eli Lilly and is also studying it for motion sickness.

The health regulator had imposed a partial clinical hold on tradipitant, preventing trials longer than 12 weeks.

The company plans to submit a separate application for the drug to prevent vomiting in motion sickness later this year.

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

((Sriparna.Roy@thomsonreuters.com;))

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