Sebelipase alfa

FDA Drug Profile — KANUMA

Drug Details

Generic Name
Sebelipase alfa
Brand Names
KANUMA
Application Number
BLA125561
Sponsor
Alexion Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients
SEBELIPASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE KANUMA ® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency. KANUMA ® is a hydrolytic lysosomal cholesteryl ester and triacylglycerol-specific enzyme indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency. ( 1 )