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www.fdanews.com/articles/198622-covid-19-pneumonia-patients-improve-on-tradipitant-vanda-says

COVID-19 Pneumonia Patients Improve on Tradipitant, Vanda Says

August 19, 2020

Hospitalized COVID-19 patients with pneumonia improved sooner when treated with Vanda Pharmaceuticals’ investigational anti-inflammatory drug tradipitant compared to a placebo, according to interim results from a phase 3 trial.

The interim analysis from an ongoing study that aims to enroll 300 participants showed that a 14- day tradipitant treatment accelerated clinical improvement by day 7.

However, the data from the first 60 enrolled patients “showed that similar percentages of patients improved between the two treatment arms, 57 percent for tradipitant and 50 percent for placebo,” Vanda acknowledged.

“The mortality rate was also similar between the treatment groups with 14.2 percent for tradipitant and 16.6 percent for placebo,” the company said.

The drug, which is licensed by Vanda from Eli Lilly, is also currently in clinical development for treatment of gastroparesis, motion sickness and atopic dermatitis.

In February 2019, Vanda sued the FDA over a partial clinical hold the agency had imposed, banning tradipitant clinical trials designed to last longer than 12 weeks until the company conducted non-rodent toxicity studies. The U.S. District Court for the District of Columbia ruled in the agency’s favor on Jan. 31 of this year (DID, Feb. 4). — Martin Berman-Gorvine