Recently, the Pulmonary-Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) issued a positive opinion and recommended the US approval of Shire’s (SHPGY) Firazyr (icatibant).
Shire is looking to get Firazyr approved in the US for treating patients (aged 18 years and above) suffering from acute attacks of hereditary angioedema (HAE). HAE is a rare genetic disease characterized by acute swelling of the hands, feet, face and larynx.
The FDA panel was convinced of Firazyr’s safety and effectiveness based on data from three double-blind, randomized late-stage studies (FAST-1, FAST-2, and FAST-3). Twelve of the 13 members of the panel recommended the approval of the drug for the indication.
Moreover, 11 of the 13 members (one member voted against the motion while the other panel member abstained from voting) recommended that the patients themselves administer Firazyr. A final decision from the FDA is expected by August 25, 2011(target date). Although the FDA is not bound to accept the recommendation of the advisory committee, it usually does so.
We note that Firazyr is currently approved in 37 nations worldwide (ex-US) including the European Union. Earlier this year, the European Commission (EC) approved a change in the label of Firazyr, following which, the label for Shire’s drug includes self-administration after training in subcutaneous injection technique by doctor.
Firazyr is the first and only medication approved in Europe for self-administration in patients suffering from acute type I and type II HAE. Approval of Firazyr in the US will substantially boost the top line at Shire.
Our Recommendation
We currently have a long-term Neutral recommendation on Shire. The company carries a Zacks #3 Rank (Hold rating) in the short term.
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