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(Circulation. 2001;104:e9017.)
© 2001 American Heart Association, Inc.

Ruth SoRelle, MPH

Circulation Newswriter

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

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 of the fact that 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. Although dyspnea, syncope, and fatigue were side effects of the drug’s administration, the committee thought its safety profile warranted approval.

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 IV symptoms were entered into the 2 studies.

Investigators hoped that after 3 months of therapy, patients in the studies would be able to walk 55 meters more in 6 minutes than they had before the study. However, the treatment group was able to walk only an average of 10 meters more after therapy, less than . . . [Full Text of this Article]