Vpriv velaglucerase alfa regulatory update

FDA issued a complete response letter for an application seeking approval of Shire's Lexington, Mass., manufacturing facility to produce Gaucher's disease therapy Vpriv velaglucerase alfa. According to Shire, the letter included questions related to specifications of the facility, in-process parameters and assays, which the company expects to resolve within 6 months. The company added that it will still be able to meet U.S. demand for Vpriv from new and existing patients through its approved Cambridge, Mass., facility. The glucocerebrosidase enzyme replacement therapy is approved in 38 countries worldwide including the U.S., Israel and countries in the EU, where it has Orphan Drug status. Vpriv recorded $71.7 million in 1Q12 sales. ...