Shire plc, the global specialty biopharmaceutical company, announced that it has submitted a complete response to the not approvable letter issued by the US Food and Drug Administration (FDA) to Jerini AG in April 2008 regarding its New Drug Application for Firazyr (icatibant) for the treatment of acute attacks of hereditary angioedema (HAE). Once the FDA acknowledges receipt of the file, a timeline for completing the review of this Class II resubmission will be communicated to Shire.
Shire’s complete response includes additional data requested by the agency regarding Firazyr’s efficacy and safety in treating HAE attacks. Shire conducted an additional phase III clinical study (FAST-3), and in December 2010 reported positive efficacy and safety results. The company’s complete response is based primarily on recent results from the FAST-3 study and the ongoing self-administration study, as well as the previously published FAST-1 and FAST-2 studies.
“It is very rewarding to announce the submission of our complete response to the FDA on February 28th, which is World Rare Disease Day,” said Sylvie Grégoire, president of Shire HGT. “As an organization we are dedicated to bringing novel therapies for rare diseases to patients; products that can make a positive impact on their lives. We look forward to continued collaboration with the FDA to bring forward an important new therapeutic option for HAE patients.”
The active substance, icatibant, is a specific bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously-administered approach to the treatment of HAE attacks designed to block the effects of bradykinin, the key mediator of edema formation. Firazyr is a synthetic decapeptide (a peptide containing ten amino acids).
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). Icatibant has an orphan drug designation status in the EU and US for treatment of hereditary angioedema. Where commercially available, the drug is supplied in a pre-filled 3 ml syringe. Firazyr can be stored at up to 25 degrees Celsius without refrigeration.
In January 2011, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for a change in the Firazyr label in the EU to include self-administered subcutaneous injections in patients who are experiencing acute attacks of HAE.
Firazyr is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.