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Jerini’s Icatibant Falters in U.S., Wins In Europe

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA rejects orphan drug for hereditary angioedema, paving way for rivals to gain an edge.

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A pivotal trial comparing Firazyr to an active comparator not approved by FDA helped bring about the first cycle “not approvable” decision. FDA’s cross-study comparison failed to show that tranexamic acid was no worse than placebo, so the trial could have made icatibant look better than it was. A third, placebo-controlled trial ultimately sealed the deal for approval.

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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.

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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