BioCentury
ARTICLE | Clinical News

Replagal agalsidase alfa regulatory update

March 19, 2012 7:00 AM UTC

Shire withdrew a BLA for Replagal agalsidase alfa to treat Fabry's disease and said it does not intend to resubmit the application. Shire said that based on recent interactions with FDA, it believes the agency will require additional controlled studies before approving the drug. The application was under Priority Review with a May 17 PDUFA date. As a result, FDA cancelled a Cardiovascular and Renal Drugs Advisory Committee meeting that was scheduled for March 27 to discuss the BLA.

Shire resubmitted the BLA last October after withdrawing a prior submission in 2010. At the time, Shire said the prolonged shortage of Fabrazyme agalsidase beta - the only Fabry's drug approved in the U.S. - would allow it to gather additional data to enhance the clinical portion of the application and potentially obtain a better label (see BioCentury, Oct. 31, 2011). ...