PDUFA date delayed for Alexion's Kanuma

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said FDA postponed the PDUFA date for a BLA for Kanuma sebelipase alfa to treat lysosomal acid lipase deficiency (LAL-D). The new PDUFA date is Dec. 8. Kanuma is under Priority Review and has breakthrough therapy designation to treat infants with LAL-D.

Alexion said it recently responded to an FDA request for additional chemistry, manufacturing and controls information, and noted that FDA did not ask for additional clinical data. ...