Recently, the US Food and Drug Administration (FDA) delivered a boost to Shire (SHPGY) by approving its drug Firazyr (icatibant). The US regulatory body has granted marketing approval to the drug for treating adults 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 approval of injectable therapy Firazyr was granted on the basis of data from three double-blind, randomized late-stage studies (FAST-1, FAST-2, and FAST-3). Data from the trials confirmed the safety and effectiveness of the drug for treating the rare genetic disease.
The FDA clearance of Firazyr, which carries an orphan drug status in the US, is highly significant as it is the first acute therapy that patients can administer themselves without a doctor’s help. Firazyr, apart from being self-administered, is highly portable and can be stored in room temperature, thereby providing patients quick access to treatment.
The FDA decision does not surprise us since in June 2011 the drug was backed for approval by the Pulmonary-Allergy Drugs Advisory Committee of the US agency for the indication. Twelve of the 13 members of the panel recommended the approval of the drug.
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.
We note that the US approval marks the 38th country in which Firazyr is approved for treating adults suffering from HAE. The 38 countries include the nations of the European Union where the therapy also has an orphan drug status. We believe that the US approval of Firazyr for treating this rare disease will further boost the top line of the Ireland-based Shire.
Our Recommendation
We currently have a Neutral recommendation on Shire. The stock carries a Zacks #2 Rank (Buy rating) in the short-run.
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