FDA Advisory Committee Shoots Down Cornerstone’s Low-Sodium Drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8–0 against recommending approval of Cornerstone Therapeutics’ lixivaptan to treat hypervolemic hyponatremia associated with heart failure. The panel also voted 5–3 this month against recommending approval of the drug to treat euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH).
Washington Drug Letter