Cornerstone dives on US FDA panel rejection of lixivaptan
This article was originally published in Scrip
Executive Summary
A US FDA panel of advisers on 13 September refused to back approval of Cornerstone Therapeutics experimental drug lixivaptan as a treatment for hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion, or SIADH, with the panel also rejecting a second indication of hypervolemic hyponatremia associated with congestive heart failure (CHF) – a double whammy that had investors fleeing from the company on 13 September.