FDA panel backs UTHR's Remodulin

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6 to 3 Thursday to recommend approval of United Therapeutics' Remodulin for the treatment of Pulmonary Arterial Hypertension (PAH), despite unusually strong skepticism about the drug that was expressed by FDA officials prior to the meeting. Robert Temple, director of FDA's Office of Drug Evaluation-I, told the advisory committee that although all of the FDA officials who reviewed the Remodulin application thought that it should not be approved, they also "found that the decision is a very close call." In two identical Phase III trials, the company failed to achieve the pre-defined level of statistical significance for the primary end point, an improvement in distance walked in six minutes. UTHR representatives argued at the meeting that they were very close to meeting the protocol-defined end point and that a variety of secondary end points suggest that Remodulin is safe and effective. ...