Drug maker Shire Plc (SHP.L, SHPGY), said Thursday its Firazyr drug for the treatment of rare hereditary angioedema has been approved by the U.S. Food and Drug Administration. Firazyr, or Icatibant, injection has been approved for use in patients aged 18 years and older with acute attacks of hereditary angioedema.
Angioedema is caused by low levels or the improper function of a protein called C1 inhibitor. Subjects with hereditary angioedema or HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death.
The FDA also approved Firazyr for self administration by patients without taking any assistance from doctors, based on the FDA advisory panel's recommendation.
"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," said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA.
The FDA approval of Firazyr was based on three controlled clinical trials in which 225 patients received 1,076 doses of 30 mg of the drug. The median time for patients treated with Firazyr to report onset of symptom relief was two hours, as compared to almost 20 hours with placebo.
Icatibant has an orphan drug status in the U.S. for treatment of hereditary angioedema. Firazyr is marketed by Shire's Cambridge, Massachusetts-based unit Human Genetic Therapies Inc.
SHPGY is currently trading on the Nasdaq at $94.85, down $1.82 or 1.88%, on a volume of 1.0 million shares, above the three-month average of 0.5 million.
On the London stock exchange, Shire closed at 1,955.00 pence, down 57.00 pence or 2.83%, on a volume of 2.9 million.
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