Shire Reports Positive Phase III Icatibant Data to Address Nonapprovable Status in U.S.
Fast-3 study data will be submitted to FDA in early 2011.!--h2>
Shire reports that data from an FDA-requested Phase III study with Firazyr® (icatibant) has confirmed that the drug significantly speeds time to relief from symptoms associated with acute attacks of hereditary angioedema (HAE). The Fast-3 study was carried out to support Shire's previously filed NDA for Firazyr in the U.S., which FDA deemed not approvable back in 2008. The firm says the Fast-3 trial data means it should now be able to file a complete response to the FDA’s nonapprovable letter during early 2011.
“These very positive and clinically meaningful results represent a significant milestone in the U.S. clinical development program for Firazyr,” notes Sylvie Gregoire, president of Shire HGT. Firazyr is currently approved in 37 countries, including the EU, for the symptomatic treatment of acute attacks of HAE in adults with a C1-INH deficiency.
The Fast-3 study involved 67 sites in 9 countries, and included 88 patients with moderate to very severe cutaneous and/or abdominal symptoms associated with HAE. Results showed that in comparison with placebo, treatment using subcutaneous Firazyr resulted in significantly faster time to onset of relief from combined symptoms, and also much faster onset of relief from the patient’s primary symptom. Median time to onset of composite symptom relief (measured as a 50% reduction in composite symptom score assessed by the patient) was 2 hours for Firazyr-treated patients, and 19.8 hours for those receiving placebo. Median time to onset of relief from the primary symptom (a 30% reduction in symptom score) was 1.5 hours for the Firazyr cohort, compared with 18.5 hours for the placebo-treated cohort.
Icatibant is a specific bradykinin B2 receptor antagonist administered by subcutaneous injection. Shire recently submitted data from the Phase IIIb EASSI study to the European Medicines Agency, to support its submission for a label amendment that would allow patients to self administer icatibant when they suffer an HAE attack.
Firazyr achieved worldwide sales of $3 million in the third quarter of 2010, up 71% on the equivalent 2009 period at constant exchange rates.