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(Circulation. 2001;104:1742.)
© 2001 American Heart Association, Inc.

Report From the 93rd Cardiovascular and Renal Drugs Advisory Committee Meeting, August 9–10, 2001

Thomas Fleming, PhD; JoAnn Lindenfeld, MD; Raymond Lipicky; Paul Armstrong, MD

Professor and ChairDepartment of Biostatistics, University of Washington
Professor of MedicineDivision of Cardiology, University of Colorado Health Science, Center
FDA Director of the Cardio-Renal Drug Products Division
Professor of MedicineUniversity of Alberta

Two new drugs for the treatment of pulmonary hypertension received tentative approval at the 93rd meeting of the US Food and Drug Administration’s (FDA) Advisory Committee Meeting on August 9 to 10, 2001. Although the committee can recommend that the FDA approve the drugs, it is not mandatory that the agency accept that recommendation.

Remodulin

The first drug, Remodulin (trepostinil sodium), which is manufactured by United Therapeutics, was approved by a vote of 6 to 3 in the committee after an animated discussion. Although the study did not achieve its primary end point, ie, a 55 meter increment in a 6-minute walk and there was no trend toward reduced mortality or need for transplantation after Remodulin treatment, the approval was based on an improvement in perceived quality of life, dyspnea score, and a reduction in other symptoms such as syncope and fatigue, coupled with a lack of safety concerns. Because of the recognized poor clinical outcomes for patients with pulmonary hypertension, as well as the complicated and logistic problems associated with the only other FDA-approved therapy for this condition (ie, Flolan), a more liberal approach to approval was used.

Remodulin, or UT-15, is a structural analogue of prostacyclin, which acts as a vasodilator in the pulmonary and systemic circulation. Its terminal half-life is 2 to 4 hours. It is administered as a continuous subcutaneous infusion.

There were two pivotal, placebo-controlled trials considered by the committee. A total of 470 patients with primary or secondary pulmonary hypertension and functional class II to . . . [Full Text of this Article]