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FDA issues non-approvable letter for Jerini over icatibant


BERLIN The Food and Drug Administration has rejected Jerini’s experimental drug icatibant, which is used to treat hereditary angiodema, a life-threatening swelling disease, according to Bloomberg.

Hereditary angioedema is caused by a genetic defect that affects a protein called C1 inhibitor. The protein is normally responsible for regulating inflammation in the body, and malfunctions can lead to rapid swelling, abdominal pain or even death if the airways become blocked.

The agency sent a non-approvable letter to Jerini, but the company has not yet disclosed what the FDA was concerned with regarding the drug. Jerini does plan to review the decision with the FDA.

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