Treatment of acute attacks of hereditary angioedema (HAE) has finally got the nod from the U. S. Food and Drug Administration. This is a human C1 esterase called Berinert, which is purified from donated blood.

The European agent has been approved for almost 20 years for prophylaxis as well as treatment of acute attacks.

HAE can be defined as a genetic disorder which involves lack of functional C1 esterase eventually leading to over-activity of the complement system. Patients suffer situations of swelling and severe pain affecting the face or abdomen.

As per the manufacturer of Berinert, CSL Behring, 6,000-10,000 people in the U. S. have the disorder.

This is a very small number of patients but companies are still making efforts to provide drugs to them. The drug is approved for adults and adolescents who have symptoms of HAE, including painful abdomen attacks and facial swelling.

Those patients who suffer a life-threatening sensitivity to C1 esterase inhibitor preparations should not take berinet. The severest side-effects of the drug reported after clinical trials include severe HAE-associated pain, headache, nausea, muscle spasms, diarrhea and vomiting, as per the agency.

German drug maker CSL Behring Inc. has produced Berinert.