FDA advisory panel backs approval of Shire's Firazyr for HAE; Replagal site cleared by EMA

In a decision that was largely expected given positive briefing papers by US Food and Drug Administration staffers ahead of the meeting (The Pharma Letter June 22), the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended, by a vote of 12 to one, that the efficacy and safety data provides substantial evidence to support approval of Ireland-headquartered drugmaker Shire’s (LSE: SHP) Firazyr (icatibant) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years and older. In addition, by a vote of 11 to one, with one abstention, the Committee recommended self-administration of the drug by patients.

The Committee's input will be considered by the FDA in its review of the New Drug Application for Firazyr, though the agency is not obligated to follow its advice. The company has been assigned an action date of August 25, 2011 under the Prescription Drug User Fee Act.

"Due to the unpredictable and potentially life-threatening nature of HAE attacks, we believe that self-administration of Firazyr can represent an effective and convenient treatment for patients to better manage their disease," said Sylvie Gregoire, president of Shire HGT. "We will continue to work closely with the FDA as it prepares to make its final decision on the FIRAZYR application."