Shire seeks approval to make Gaucher disease drug at new plant

Drug maker applies with FDA, EMA to make Vpriv in Lexington, Mass.

LEXINGTON, Mass. — British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.

The company said Tuesday that it had filed with the Food and Drug Administration and the European Medicines Agency for approval to produce the Gaucher disease drug Vpriv (velaglucerase alfa) at its Lexington, Mass., plant. The company expects to win approval to make the drug there early next year.

After gaining approval, the company said it hopes to ramp up manufacturing of the Fabry disease drug Replagal (agalsidase alfa) at its plant in Alewife, Mass., near Boston, where it currently makes Replagal and Vpriv. Replagal is approved in 46 countries, but not the United States. Currently, 1,200 people receive Vpriv and 2,800 receive Replagal worldwide, according to the company.

"Shire remains committed to meeting the unique needs of patients living with rare diseases," Shire Human Genetic Therapies SVP technical operations Bill Ciambrone said. "Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for Vpriv less than two years after launch. Once approved, this new facility will give us greater flexibility to meet the global demand for Vpriv, as well as some of our other products for rare diseases."


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