(dailyRx)

The FDA has approved Kalbitor (ecallantide) to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).
HAE is caused by a defect in the blood protein C1 esterase-inhibitor, which plays a role in regulating how certain immune system and blood-clotting pathways function. Decreased function of this protein can lead to rapid and serious swelling of the face or other parts of the body, which may result in permanent disfigurement, disability or death.  Swelling of the digestive tract may cause excruciating abdominal pain, nausea and vomiting, while airway swelling puts patients at risk of suffocation. About 10,000 people in the U.S. have HAE.

"Kalbitor offers another potentially life-saving option for those people with HAE," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "[The] FDA is committed to facilitating the development and approval of safe and effective therapies for patients with rare conditions."

This medication, marketed by Dyax, is injected under the skin for patients age 16 and older who experience HAE attacks.  Kalbitor is the second marketed in the U.S. to treat HAE attacks. In October 2009, the FDA approved CSL Behring's Berinert, a C1 inhibitor derived from blood plasma to treat facial and abdominal attacks of HAE.

Kalbitor's most serious side effect is anaphylaxis, a severe allergic reaction that can close a person's airways and stop him or her from breathing. Other side effects include headache, nausea, diarrhea, swelling in the nose and throat, fever and skin irritation. The medication should only be administered by a health care professional with appropriate medical support to manage anaphylaxis.

Contact:
Karen Riley
301-796-4674
karen.riley@fda.hhs.gov