ecallantide

The drug was called ecallantide, but Cubist is now designating it as CB-500,929.

unknown title 2009

Dyax, of Cambridge, Mass., said in meeting documents also posted to FDA's Web site that ecallantide "has been demonstrated to be safe and effective for patients suffering from [heredity angioedema]."

FDA Questions Effectiveness of Dyax Drug for Rare Disorder 2009

The panel will also be asked to vote on whether ecallantide should be approved for use in patients 10 to 17 years old as well as those 18 and older.

FDA Questions Effectiveness of Dyax Drug for Rare Disorder 2009

If approved, ecallantide would likely be sold under the brand name Kalbitor.

FDA Questions Effectiveness of Dyax Drug for Rare Disorder 2009

The agency said, in documents prepared for the meeting, one study of the drug didn't meet a goal of showing a statistically significant improvement in symptoms compared to placebo, although the study showed a greater number of patients in the ecallantide group had an improvement compared to placebo.

FDA Questions Effectiveness of Dyax Drug for Rare Disorder 2009

The panel is being asked to vote on whether it thinks ecallantide is safe and effective, which would amount to a recommendation to the FDA about whether the drug should be approved.

FDA Questions Effectiveness of Dyax Drug for Rare Disorder 2009

The proposed treatment, ecallantide, is designed to partly block an enzyme known as kallikrein involved with the disorder.

FDA Questions Effectiveness of Dyax Drug for Rare Disorder 2009

Our lead product, DX-88, has been approved under the brand name KALBITOR® (ecallantide) in the United States for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

The Earth Times Online Newspaper 2010

The decision follows the Lexington, Mass., company's December announcement that it was halting enrollment into phase 2 trials for the drug, ecallantide, citing disparities in trial data that may indicate unexpectedly high mortality rates.

Los Angeles Business News - Local Los Angeles News | Los Angeles Business from bizjournals 2010

The decision to wind down its ecallantide operation, Cubist also said it will end a licensing agreement with

Los Angeles Business News - Local Los Angeles News | Los Angeles Business from bizjournals 2010