US FDA approves Shire's Firazyr to treat acute attacks of hereditary angioedema

After a near unanimous recommendation from an advisory panel earlier this year (The Pharma Letter June 27), the US Food and Drug Administration yesterday approved Ireland-headquartered Shire’s (LSE: SHP) Firazyr (icatibant) Injection for the treatment of acute attacks of the rare condition hereditary angioedema (HAE) in people aged 18 years and older.

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.

The drug is already marketed in 37 countries. The European Commission has approved Firazyr for self-administration after training in subcutaneous injection technique by a health care professional. Firazyr is the first and only treatment for acute Type I and Type II HAE attacks licensed for self-administration in Europe. It has an orphan drug designation status in the European Union and the USA for treatment of hereditary angioedema. According to analysts polled by Bloomberg, Firazyr could generate sales $48 million next year and nearly $200 million.