Shire plc, the global specialty biopharmaceutical company, announced topline results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of the Phase III trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).
The study showed that patients receiving treatment with Firazyr experienced a significantly faster time to onset of symptom relief from individual and combined cutaneous and abdominal HAE symptoms, compared to those receiving placebo.
Firazyr provided a highly statistically significant and clinically meaningful benefit relative to placebo for the primary endpoint of time to onset of symptom relief for the first attack after study enrollment. This was measured by 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 of the patient’s primary (main) symptom. This secondary efficacy endpoint was measured by a 30% reduction in symptom score. The median time to onset of relief for Firazyr by this measure was 1.5 hours, compared with 18.5 hours for placebo.
The results for both of these endpoints were highly statistically significant (p<0.001).
Consistent with previous studies, Firazyr was generally well tolerated.
Firazyr is currently approved in 37 countries worldwide, including the countries of the European Union, for the symptomatic treatment of acute attacks of HAE in adults (with a C1-INH deficiency). In 2008 the U.S. Food and Drug Administration (FDA) issued a not approvable letter for Firazyr. It was agreed by Shire and the agency that an additional clinical study (FAST-3) would be required to support the New Drug Application (NDA) filing in the US. Shire now expects to file a complete response to the FDA’s not approvable letter early in 2011.
“These very positive and clinically meaningful results represent a significant milestone in the U.S. clinical development program for Firazyr,” said Sylvie Grégoire, President of Shire HGT. “We are currently preparing our complete response and we look forward to working with the FDA to provide Type 1 and Type 2 HAE patients in the U.S. with an additional treatment option that holds the potential to offer quick access to effective treatment.”
Date: December 1, 2010
Source: Shire plc