FDA approves Kalbitor For Angioedema

Dyax has received FDA approval to market Kalbitor, indicated for the treatment of hereditary angioedema in patients 16 years and above.

Angioedema is the rapid swelling of the dermis, subcutaneous tissue, mucosa and submucosal tissues.

Reportedly, the drug is an injectable treatment approved in the US. Kalbitor is also being evaluated for treatment of blood loss during heart surgery by Cubist Pharmaceuticals.

As part of the approval the company has set up a program to inform users about the risk of anaphylatic shock and the importance of determining the difference between hypersensitivity to the drug and a hereditary angioedema attack, reported Business News.