Kalbitor Approved to Treat Acute Hereditary Angioedema Attacks

On December 1, 2009, Dyax Corp. received Food and Drug Administration (FDA) approval for Kalbitor (ecallantide), the first injectable medication approved to treat all symptoms of hereditary angioedema (HAE) attacks in patients 16 years of age and older.

“HAE is a rare, debilitating, and potentially fatal genetic condition that results in a protein deficiency of C1 esterase inhibitor,” said Dr. Mark Riedl, assistant professor of clinical immunology and allergy at UCLA. “Because of the inherited protein deficiency, these patients have intermittent episodes of tissue swelling that can affect the skin, the gastrointestinal tract, or the airway.”

The non-itching episodes of tissue swelling often occur without warning, especially during periods of stress, surgery or infection, and patients report an average of one episode per month. Attacks are often accompanied by abdominal cramping, vomiting, weakness, and diarrhea that can last up to five days. Patients often require hospitalization for pain management and rehydration.

When used during an HAE attack, Kalbitor can help slow the progression of swelling and keep the airway and larynx from becoming completely blocked, potentially saving the patient’s life. Since HAE attacks are not allergy-related, patients are not able to use antihistamines, corticosteroids, or epinephrine to relieve swelling.

The approval of Kalbitor marks the first drug approved to treat all symptoms of an HAE attack. Previously, HAE patients had access to the FDA-approved Cinryze, indicated for preventative treatment of HAE attacks only. In October 2009, the FDA approved Berinert for the treatment of abdominal and facial swelling associated with HAE attacks.

Dyax expects to launch Kalbitor in early 2010.