Monday, August 13, 2001
FDA's review of United Therapeutics Corp.'s Remodulin treprostinol was so consistently negative that it seemed unlikely the Cardiovascular and Renal Drugs Advisory Committee would vote in favor of approval of the drug to treat pulmonary arterial hypertension (PAH). Yet FDA's analysis masked a more nuanced uncertainty, and the clinical perspective of the panel members last week led them to the opposite conclusion.
The FDA's review was so bearish that Robert Temple, director of CDER's Office of Drug Evaluation-I, felt it necessary to tell the committee why it was taking the time to solicit its advice. "The Cardio-Renal Division reviewers and supervisors have consistently reached the conclusion that treprostinol should not be approved. Does that mean we all think what to do is clear? No. That's why we are here," Temple told the committee.