Zacks_Analysts' Blog : Action Date for Shire's Firazyr - Analyst Blog

Shire (SHPGY) recently announced that the US Food and Drug Administration (FDA) has issued a new action date for Firazyr (icatibant). The FDA is treating Shire’s response to the agency’s complete response letter (CRL) as a class II resubmission and has set a target date of August 25, 2011.

Shire is looking to get Firazyr approved in the US for treating acute attacks (types I and II) of hereditary angioedema (HAE). HAE is a rare genetic disease characterized by acute swelling of the hands, feet, face and larynx.

In February 2011, Shire submitted a response to the not-approvable letter issued by the US agency for Firazyr in 2008. We note that the response of the Irish company was based on positive safety and efficacy data from a late-stage study (FAST-3) presented in December 2010.

The randomized, double blind, placebo controlled multicenter trial evaluated Firazyr in 88 patients with acute attacks of HAE. Shire’s response also included data from other studies (FAST-1 and FAST-2).

We note that Firazyr is currently approved in 37 nations worldwide (ex-US) including the European Union. Earlier in the month the European Commission (EC) approved a change in the label of Firazyr.

Following the approval of the label change by the European regulatory authorities, 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.

Shire Presents Positive Data

Recently, Shire presented encouraging data on its Gaucher drug Vpriv and Fabry disease drug Replagal at a medical conference in Vancouver. Data revealed that it was safe to switch to Vpriv from Genzyme Corporation’s (GENZ) Cerezyme, for patients suffering from type I Gaucher disease. Data also suggested that it was safe to switch to Replagal from Genzyme’s Fabrazyme for patients suffering from Fabry disease.

Our Recommendation

We currently have a Neutral recommendation on Shire, which is supported by a Zacks #3 Rank (short-term Hold rating).