ARTICLE | Clinical News

Replagal agalsidase alfa regulatory update

August 9, 2010 7:00 AM UTC

Shire disclosed in its 2Q10 financial results that it withdrew a rolling BLA for Replagal agalsidase alfa to treat Fabry's disease. On a conference call, Shire said the prolonged shortage of Fabrazyme agalsidase beta from Genzyme Corp. (NASDAQ:GENZ, Cambridge, Mass.) will allow Shire to gather additional data to enhance the clinical portion of the application and potentially obtain a better label. Shire is already providing access to the injectable alpha-galactosidase A (Alpha-gal A) enzyme in the U.S. under a treatment protocol. Fabrazyme has faced supply shortages since June 2009 due to viral contamination and other problems at Genzyme's Allston, Mass. facility (see BioCentury, Oct. 26, 2009). ...