Biotech, FDA, Drugs

Dyax Hit With FDA Drug Delay

Luke Timmerman 3/27/09

Cambridge, MA-based Dyax (NASDAQ: DYAX) said today that its lead drug in development, DX-88, failed to win FDA approval on schedule. The company said it needs to answer more questions about the chemistry, manufacturing, and controls section of its application, and for a risk evaluation and mitigation strategy. The company doesn’t need to do more clinical trials. The product is for treating acute attacks of hereditary angioedema, a condition that causes painful swelling of the extremities.

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.