Dublin-based pharmaceutical firm Shire Plc (SHPGY,SHP.L) Monday said that the U.S Food and Drug Administration has assigned a Prescription Drug User Fee Act, or PDUFA, date of August 25, 2011 for the review of the New Drug Application for FIRAZYR, or icatibant, for treatment of acute attacks of hereditary angioedema or HAE, a rare genetic disease.
HAE is characterized by recurrent sudden attacks of edema or swelling of skin or mucous membranes, which can be disfiguring and painful, especially in case of abdominal attacks.
The company noted that the six-month review timeline is consistent with review as a Class II resubmission.
Shire said its complete response to the not approvable letter from FDA provides additional data requested by the agency regarding FIRAZYR's efficacy and safety. Further, the company noted that it has conducted an additional Phase III clinical study and reported positive efficacy and safety results in December 2010.
The company said its complete response is based on recent results from FAST-3 study and the ongoing self-administration study, as well as the previously published FAST-1 and FAST-2 studies.
FIRAZYR is a synthetic decapeptide, or a peptide containing ten amino acids, which is the first and only treatment for acute Type I and Type II HAE attacks licensed for self-administration in Europe.
Type I and Type II HAE are caused by low levels or a dysfunction of C1 esterase inhibitor, which can lead to elevated plasma levels of bradykinin, the key mediator of HAE symptoms.
The active substance icatibant is a specific bradykinin B2 receptor antagonist, which represents a novel, targeted, subcutaneously-administered approach to the treatment of HAE attacks designed to block the effects of bradykinin, the company said.
Shire stated that FIRAZYR has an orphan drug designation status in the EU and US for the treatment of HAE.
SHPGY closed Friday's regular trading at $88.05 on the Nasdaq.
SHP.L is currently trading at 1,832 pence, up 13 pence or 0.71 percent, on a volume of 237 thousand shares.
For comments and feedback contact: editorial@rttnews.com
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.