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.
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