Shire Gets Advisory Committee Support For Firazyr Self-Administration Claim
Shire will enter discussions with FDA on labeling for its hereditary angioedema drug Firazyr (icatibant) with backing from an advisory panel for a claim to allow patients to self-administer the product, which is delivered through subcutaneous injection.
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The Center for Devices and Radiological Health recommended a delay in approving Firazyr until a human factors study could be conducted to rule out risks associated with the self-administration device, but CDER reviewers concluded that experience with the device in clinical trials and real life was sufficient to demonstrate safety.
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