ARTICLE | Clinical News

Replagal agalsidase alfa regulatory update

March 1, 2010 8:00 AM UTC

Shire withdrew a BLA for Replagal agalsidase alfa to treat Fabry's disease. The company, which submitted the BLA in December, made the decision after FDA requested additional human pharmacokinetic data to confirm the comparability between product manufactured in roller bottles and product manufactured in bioreactors. Shire now plans to immediately resubmit Replagal for approval as a rolling BLA and submit the requested pharmacokinetic data around mid-year. FDA also granted Fast Track designation for the injectable alpha-galactosidase A (Alpha-gal A) enzyme in the indication. ...