Dyax has taken a big step toward gaining FDA approval on its first drug. An expert committee narrowly voted to recommend the use of ecallantide--DX-88--for acute attacks of hereditary angioedema. The drug squeaked through on a vote of six to five in favor, with two abstentions.
The committee's endorsement came despite some heavy criticism leveled by FDA staffers. In a review, the agency workers said that Dyax's studies did not present a clear picture of the drug's effect. And they raised worries about severe allergic reactions recorded during trials.
But the committee members voting in favor of the drug noted that while ecallantide isn't perfect, treatments for HAE are badly needed. As Xconomy notes in its story, Dyax is in a race with ViroPharma and Shire to gain approval of a new therapy for HAE. The rare blood disease affects some 10,000 patients globally.
"We are committed to establishing safe use conditions for DX-88, if approved, and will work with the FDA to ensure our post-marketing program achieves this goal," said Dyax CEO Gustav Christensen.
- check out Dyax's release
- read the report from Xconomy