Firazyr for Hereditary Angioedema Passed for FDA’s Final approval

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A medication for treatment of hereditary angioedema in patients whose age is above is 18 years namely Firazyr (22150, icatibant solution) became a subject for voting in   FDA Pulmonary-Allergy Drugs Advisory Committee. The votes were 11 of 12 in favour of Firazyr. The committee’s recommendations are although void; however FDA favours Committee’s advice. But the final decision by FDA is still waited which will be declared on August 25th, 2011.

According to the manufacturers of Firazyr, Shire PLC which is a pharmaceutical company in UK, the data available is potential evidence which supports the approval of FIRAZYR for treatment of minor attacks of hereditary angioedema (HAE) in patients aged 18 years or more. The Committee also advises that the drug should be approved for self administration i.e. one which can be injected by patient himself/herself.

Hereditary Angiodema

The President of Shire HGT, Sylvie Gregoire says that since HAE attacks are very unpredictable and life threatening, self administration of Firazyr will prove be an effective treatment for patients to react spontaneously to the disease. The committee also evaluated three double-blind phase three studies which was absolutely random namely the FAST-1, FAST-2 and FAST-3 trails. Some patients had cutaneous, laryngeal and abdominal attacks and Firazyr was reported as a very beneficial drug for patients with hereditary angioedema.

Shire also said administering 30 mg of Firazyr subcutaneously for treating acute attacks worked pretty well and well tolerated in safety profile. It was found that this medication works after two hours of administration which is much less than 19.8 hours of placebo.

Angioedema or Quincke’s edema refers to edema i.e. rapid swelling of deep dermis, subcutaneous tissue, mucosa and submucosal tissues or briefly swelling of the deep layers of skin. It resembles hives in which there’s a swelling in skin’s surface. There are patients who are suffering from both simultaneously. Growing angioedema is taken as a medical emergency since it can cause suffocation. If angioedema is caused due to allergic reaction, epinephrine (adrenalin injection) is given to the patient but it does not work well for hereditary angioedema.

Basically there are four kinds of angioedema which are allergic, idiopathic, drug induced and hereditary. Hereditary angioedema is the rarest of all which is caused when individuals inherit faulty genes. Patients have urticaria and blood levels of C1-1NH protein are significantly low. Symptoms grow gradually and are seen only after puberty which may also be triggered by factors like infection, trauma, contraceptive pills or pregnancy. Patients with hereditary angioedema may also experience vomiting, diarrhoea, nausea, tummy pain and rarely pain in urination.