The FINANCIAL — Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, on February 28 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.”
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