Firazyr Approved by FDA for Angioedema Treatment
by Rizza Estanilla in Diseases on Sep 23, 2011
Icatibant subcutaneous injection or Firazyr has been approved by the U.S. Food and Drug Administration (FDA) as a treatment of HAE or hereditary angioedema’s acute attacks, especially in people aging eighteen years or above.
The treatment is a bradykinin B2 receptor antagonist and is offered in a pre-filled syringe, which can be kept inside rooms having the regular room temperature up til 77 degrees Fahrenheit for immediate use and portability.
According to the director of the Office of Drug Evaluation II in the Center for Drug Evaluation and Research in FDA, Curtis Rosebraugh, MD, MPH, Firazyr is providing a fresh new choice in treating HAE’s acute attacks; and since it can be done by oneself by means of an injection in the abdominal area. Additionally, the patients can immediately treat themselves seeing that they are experiencing the attack of HAE.
The approval was rooted from the records coming from three double-blind controlled and randomized clinical trials, with a total number of 223 participants. This showed a dosage of thirty milligrams of Icatibant appreciably lessened the mean time in symptom relief, which is in relation with placebo.
The results of the research were substantiated by a thorough analysis of data from the chosen clinical trials. The patients who took Icatibant have gone through a reduction of fifty percent from the basic symptoms during the mean time of 2 to 2.3 hours. The gap did not differ when the treatment was repeated for the first five attacks of HAE. Majority of the patients were resolved with just a single dosage came up with 93 percent. The effectiveness also did not differ regarding nonlaryngeal versus laryngeal sites of attack, nor with the clinician administration of medication versus patient.
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