FDA approves Vpriv

FDA approved an NDA from Shire plc (LSE:SHP; NASDAQ:SHPGY) for Vpriv velaglucerase alfa to treat Type I Gaucher's disease. Shire plans to launch the glucocerebrosidase enzyme replacement therapy immediately. The wholesale acquisition cost (WAC) of a 400 unit vial of Vpriv will be $1,350, which Shire said is a 15% discount to the price of Cerezyme imiglucerase from Genzyme Corp. (NASDAQ:GENZ).

FDA noted that Cerezyme, the only other marketed enzyme replacement therapy in the U.S. for the indication, is in "short supply." Genzyme experienced supply constraints for Cerezyme after the shutdown of the company's Allston, Mass., manufacturing plant last June due to viral contamination. Genzyme said last week it would ship Cerezyme at a rate to meet 50% of demand for a period of eight weeks although it did note that it is now producing the drug at greater than average yields. ...