Phase III trials for the treatment of hereditary angioedema

Journal of Drugs in Dermatology, Nov-Dec, 2006 by Marissa Heller

Kos Pharmaceuticals, Inc, recently announced positive preliminary results from 2 Phase III trials of Icatibant for the subcutaneous treatment of hereditary angioedema. Icatibant is a synthetic peptidomimetic that works by blocking the B2 receptor as it acts as an antagonist to bradykinin. Since bradykinin is elevated in patients with hereditary angioedema, and since it is thought to be responsible for the edema that forms during attacks, Icatibant is effective in treating hereditary angioedema.

In these Phase III studies, Icatibant was compared to placebo. Both studies showed a significant reduction in time to onset of relief of symptoms in the patients treated with Icatibant--2.5 hours as compared to 4.6. hours for placebo. The FDA has granted orphan drug status and fast-track designation for Icatibant in the treatment of hereditary angioedema.