Shire’s Firazyr for Hereditary angioedema receives FDA approval

Earlier on Thursday, Dublin-based Shire PLC announced that the drug Firazyr has been approved by the Food and Drug Administration for treating hereditary angioedema.

Hereditary angioedema, which affects below 30,000 people in the US, is a rare inherited condition causes rapid and dangerous swelling in the limbs, face, windpipe, intestines, and other internal organs, and the drug Firazyr was approved to treat flare-ups, which can lead to disfigurement and even fatalities.

Firazyr is a first injectable treatment that does not necessitate physician intervention for administration. Hereditary angioedema is caused by low levels or dysfunction of a protein that controls blood clotting and other biologic responses. Previously, two other drugs had received FDA approval for this indication.

Director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, Curtis Rosebraugh, M.D., M.P.H., said: “Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack.”

FDA approval was received based on three studies wherein 225 patients received 1,076 doses of 30 mg Firazyr. Patients taking Firazyr were relieved of their symptoms after two hours, while those on placebo took 20 hours. Reported side effects with Firazyr use were injection site reactions, fever, increased liver enzymes, dizziness, and rash.

In morning trading, shares of Cambridge, Mass based Shire declined $1.46, or 1.5 percent, to $95.21.