BioCentury
ARTICLE | Regulation

FDA panel rebuffs Topol, Medicines Co

October 26, 1998 8:00 AM UTC

BETHESDA, Md - An FDA advisory committee on Friday voted 5 to 3 to recommend against approval of The Medicines Co.'s Hirulog (bivalirudin) anticoagulant for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for the treatment of unstable angina.

The meeting was marked by emotional exchanges between members of the Cardiovascular and Renal Drugs Advisory Committee and Eric Topol of The Cleveland Clinic Foundation, one of the world's leading authorities on coronary intervention...