EMA approves Shire Vpriv plant in USA

Ireland-headquartered biopharma firm Shire (LSE: SHP) says that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has approved the production of Gaucher disease drug Vpriv (velaglucerase alfa) in its new state-of-the-art manufacturing facility in Lexington, Massachusetts, USA.

The new facility was built at a cost of more than $200 million, and has been approved by US regulators, and will receive formal recognition from the US Green Building Council this quarter. The European Commission's decision based on the CHMP recommendation is expected imminently, and will allow Shire to market the product made at the Lexington plant.

"We welcome the news that Shire's new manufacturing facility in Lexington has received EMA approval for the production of Vpriv," said Tanya Collin-Histed of the European Gaucher Alliance, adding: "This provides patients with greater comfort over the maintenance of supply of enzyme therapies for the treatment of Gaucher disease."