Shire plc, the global specialty biopharmaceutical company, announced that the Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended, by a vote of twelve to one, that the efficacy and safety data provides substantial evidence to support approval of FIRAZYR (icatibant) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years and older. In addition, by a vote of eleven to one, with one abstention, the Committee recommended self-administration of the drug by patients.
The Committee’s input will be considered by the FDA in its review of the New Drug Application for FIRAZYR. The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. The Company has been assigned an action date of August 25, 2011 under the Prescription Drug User Fee Act.
“Due to the unpredictable and potentially life-threatening nature of HAE attacks, we believe that self-administration of FIRAZYR can represent an effective and convenient treatment for patients to better manage their disease,” said Sylvie Grégoire, President of Shire HGT. “We will continue to work closely with the FDA as it prepares to make its final decision on the FIRAZYR application.”
In considering whether FIRAZYR is safe and effective, the Committee considered data from three double-blind, randomized, controlled phase 3 trials, known as the FAST-1, FAST-2, and FAST-3 studies. The results from these trials, which included patients with cutaneous, abdominal, and laryngeal attacks, provided substantial and convincing evidence of clinically meaningful benefit of FIRAZYR for the treatment of acute HAE attacks in adults. Treatment of acute attacks with 30 mg of FIRAZYR administered subcutaneously was generally well tolerated with a consistent safety profile across all clinical studies. Key study symptom measures included time to onset of symptom relief, based on measures of abdominal pain, skin pain, skin swelling, and measured time to a clinically relevant effect for the primary (main) symptom of attack from the patient’s perspective.
In FAST-3, FIRAZYR provided a statistically significant and clinically meaningful benefit relative to placebo for the primary endpoint of time to onset of symptom relief, which was defined as a 50% reduction in a composite symptom score assessed by the patient. The median time to onset of symptom relief for FIRAZYR by this measure was 2.0 hours, compared with 19.8 hours for placebo. FIRAZYR also provided a significantly shorter time to onset of symptom relief for the patient’s primary symptom. The median time to onset of relief for FIRAZYR by this measure was 1.5 hours, compared with 18.5 hours for placebo. For both of these endpoints, the differences between FIRAZYR and placebo were statistically significant (p
A Phase 3b Evaluation of the Safety of Self-Administration with Icatibant (EASSI) study showed that self-administration of FIRAZYR for acute attacks of HAE was generally well-tolerated. Times to symptom relief following FIRAZYR administration were similar whether self-administered or administered by a healthcare professional, and consistent with the Phase 3 data.
Across the studies, almost all patients experienced injection site reactions which were transient and generally did not require clinical intervention. Other common adverse reactions included nausea, fever, dizziness, headache, and rash. The safety experience reported in the self-administration study was similar.
Date: June 23, 2011
Source: Shire plc
Filed Under: Drug Discovery
