Shire plc has won approval from the European Commission to market its Gaucher disease treatment, called VPRIV, to 30 countries in Europe.
The drug, which was approved in the U.S. by the Food and Drug Administration in March, is an enzyme replacement therapy intended for long-term treatment of type 1 Gaucher disease.
Gaucher disease affects only one in every 50,000 people. It causes enlargement of the spleen and liver, among other symptoms and can be fatal.
“Our efforts to accelerate our manufacturing, clinical and regulatory timelines have resulted in VPRIV’s approval in Europe and the US months ahead of schedule,” said Sylvie Gregoire, president of Shire Human Genetic Therapies, in a press release today.
The European marketing approval of VPRIV also aids Gaucher disease patients who have been affected by a shortage of Genzyme Corp.’s Gaucher disease drug, Cerezyme, due to a temporary shutdown of Genzyme’s Allston manufacturing plant last summer.
U.K.-based Shire has its Human Genetics Therapies division headquartered in Cambridge and Lexington.