Lixivaptan regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approval of Cornerstone's lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH). The committee voted 8-0 against the CHF indication and 5-3 against the SIADH indication. Lixivaptan has an Oct. 29 PDUFA date.

In briefing documents released last week, an FDA reviewer said "an argument can be made" for approval of the SIADH indication, but recommended a complete response letter be issued for the CHF indication. The reviewer said lixivaptan had a "modest" effect on raising serum sodium in 3 Phase III trials, but also led to an increase in deaths in CHF patients compared to placebo in 1 of the trials. ...