Rheumatoid Arthritis

Phase IIb clinical trials of Pralnacasan discontinued due to toxicity

Published in Medical Letter on the CDC and FDA, December 14th, 2003

Aventis and Vertex Pharmaceuticals Incorporated (VRTX) announced voluntary discontinuation of phase IIb clinical trials of pralnacasan, an oral interleukin-1 beta converting enzyme (ICE) inhibitor, in rheumatoid arthritis (RA).

This decision is based on results from an animal toxicology study that showed liver abnormalities after a 9-month exposure to pralnacasan at high doses. There have been no significant adverse events associated with liver toxicity in subjects and patients who participated in pralnacasan studies to date.

The decision was confirmed following a discussion with the Food and Drug Administration (FDA) that Aventis and Vertex had...

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Source: Medical Letter on the CDC and FDA (2003-12-14)

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