FDA review pans UTHR's Remodulin

The FDA on Wednesday released a scathing review of United Therapeutics' Remodulin to treat pulmonary arterial hypertension (PAH). Data for the product will be considered by the FDA's Cardiovascular and Renal Drugs Advisory Committee on Aug. 9. In a memo released to advisory committee members, Raymond Lipicky, director of FDA's division of Cardio-Renal Drug Products concluded that results submitted by UTHR "do not support approval of [Remodulin] for the treatment of pulmonary arterial hypertension."

Lipicky noted that the company failed to meet its primary efficacy end point, a statistically significant improvement in distance walked in six minutes by PAH patients, in two identical trials. Lipicky noted that over the course of the 12-week trials, there was a decrease in mean distance walked by patients treated with Remodulin, but the decrease was less than that experienced by patients who received a placebo. The treatment benefit was approximately 7%, a change that Lipicky characterized as "small" and not clinically meaningful. ...