GREENWICH THERAFECTIN POSITIVE PIVOTAL STUDY NEEDS REPLICATION

Executive Summary

GREENWICH THERAFECTIN POSITIVE PIVOTAL STUDY NEEDS REPLICATION, FDA's Arthritis Advisory Committee decided after reviewing data from two pivotal and two supporting studies presented by the company Jan. 27. The advisory committee voted five to zero with two abstentions that the database for Greenwich Pharmaceuticals' Therafectin (amiprilose) does not support approval for treatment of rheumatoid arthritis. The committee agreed that pivotal study RA-9 showed the agent to be efficacious compared to placebo but felt that the other studies were inconclusive.