On Friday, the U. S. Food and Drug Administration gave consent to Shire Plc's Vpriv drug to treat children and adults with the most common form of gaucher disease.
The injectable drug will treat patients with Type 1 Gaucher disease and serve as a substitute to Genzyme's Cerezyme, which is in short supply due to manufacturing problems.
Julie Beitz, Head of the FDA Office said, "Patients who previously received Cerezyme as an enzyme replacement therapy for their Type 1 Gaucher disease can safely switch to Vpriv".
Shire plans to sell its drug at a 15% discount over Genzyme's drug and hopes to launch Vpriv in Europe later this year and in other countries starting in 2011.
The FDA said that there are some side effects to Shire's Vpriv such as allergic reactions, headache, dizziness, abdominal pain, joint pain, fever and delayed blood clotting.
Gaucher disease affects people who are short of a certain enzyme, according to the agency. Too much fat builds up in the body and prevents organs from working.
According to the U. S. National Institutes of Health, Type 1 Gaucher disease is more prevalent in people of Ashkenazi Jewish ancestry. On the whole, the disorder occurs in about 1 in 50,000 to 1 in 100,000 people.
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