BioCentury
ARTICLE | Regulation

Pivotal week for two drugs

June 6, 1994 7:00 AM UTC

Two biotech products coming up for FDA panel review later this week - Centocor Inc.'s ReoPro and a new label for Genentech Inc.'s Activase - are likely to spark some spirited discussion.

Debate on CNTO's ReoPro (formerly CentoRx) antibody fragment is likely to revolve around bleeding complications seen in the EPIC trial of 2,099 high-risk angioplasty patients. The drug significantly reduced adverse events at 30 days, including heart attacks, death, and need for repeat angioplasty and coronary artery bypass graft surgery; the benefit of the drug over placebo was maintained at six months...