New Drug Studied for Hard-to-Treat Vascular
WEDNESDAY, Aug. 4 (HealthDay News) -- A drug called icatibant is
effective in treating acute attacks of a condition that causes
potentially life-threatening swelling in the throat and other parts
of the body, new research shows.
People with hereditary angioedema (HAE) suffer recurrent
episodes of swelling caused by fluid leaking from blood vessels. It
can occur in a number of areas, including the face, extremities,
gastrointestinal tract or the throat and larynx, where it can cause
dangerous blockage of the airway, researchers explained in a news
release from Massachusetts General Hospital in Boston, where one of
two recent trials of the drug was based. The other trial was in
The condition is caused by low levels or poor function of a
protein called C1 esterase inhibitor. The new drug, icatibant,
blocks the receptor for a protein called bradykinin, which is
thought to play a role in many HAE symptoms.
By interfering with bradykinin's normal actions, which include
dilating blood vessels and producing symptoms of inflammation,
icatibant prevents HAE's abnormal swelling, the researchers
"We have not had many options for treating painful, debilitating and potentially life-threatening attacks of hereditary angioedema, and these studies showed that icatibant improves symptoms and is not associated with any concerning side effects," explained Dr. Aleena Banerji, principal investigator for the Massachusetts General Hospital study site.
Icatibant has already been approved in the European Union. As
part of its application to have the drug approved by the U.S. Food
and Drug Administration, German drug maker Jerini Inc., conducted
the two randomized, double-blind clinical trials, which included a
total of 130 patients.
Although the results of one trial did not reach statistical
significance, the researchers concluded that icatibant is safe and
effective in treating acute attacks of HAE. No serious
treatment-related side effects were reported in either trial,
according to the findings published in the Aug. 5 issue of the
New England Journal of Medicine.
Currently available treatments for U.S. patients with the
condition include C1 esterase inhibitor infusions and, for acute
reactions, an injected drug that inhibits an enzyme called
kallikrein. The shot can only be given by a health care
professional due to the risk of life-threatening allergic
A larger, worldwide phase 3 trial of icatibant is currently
The U.S. National Library of Medicine has more about
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