FDA Approves Armour's Mononine, the First Monoclonal Antibody-Purified Hemophilia B Therapy
核心洞察
The FDA approved Armour's Mononine on August 20 for preventing and controlling bleeding in Hemophilia B (搜索) patients with Factor IX deficiency (搜索).
Mononine, a Coagulation Factor IX, is the first monoclonal antibody-purified Hemophilia B (搜索) therapy, priced at $1.04 per unit.
The therapy is available in single-dose vials of 250, 500, and 1000 IUs, administered at approximately 2.0 ml per minute when reconstituted.
The U.S. Food and Drug Administration (FDA) has approved Armour's Mononine, a Coagulation Factor IX, for the prevention and control of bleeding in patients with Hemophilia B (搜索) (Factor IX deficiency (搜索)). This approval marks a significant advancement in hemophilia treatment as Mononine is the world's first monoclonal antibody (MAb) purified Hemophilia B therapy.
Mononine, developed by Rhone-Poulenc Rorer (搜索) subsidiary Armour, is supplied in single-dose vials of 250, 500, and 1000 International Units (IUs). The approved labeling specifies that when reconstituted to approximately 100 units/ml, Mononine should be administered at a rate of approximately 2.0 ml per minute. Each milliliter of the reconstituted concentrate contains approximately 100 IU of Factor IX and non-detectable levels of Factors II, VII, and X.
The average wholesale price for Mononine is set at $1.04 per unit. However, Mononine is contraindicated in patients with hypersensitivity to mouse protein, a critical consideration for prescribing physicians.
Notably, the FDA also recently approved two other Factor IX biologics: Alpha Therapeutics (搜索)' AlphaNine SD (Coagulation Factor IX) on August 26, and Oesterreichisches Institut (搜索)'s Bebulin VH Immuno (搜索) (Factor IX Complex) on August 19. AlphaNine SD is an improved version of Alpha Therapeutics' AlphaNine, featuring a solvent/detergent viral inactivation process using tri-n-butyl phosphate (TNBP) and Polysorbate 80. This enhancement reduces non-Factor IX proteins, augmenting the product's safety and purity. Oesterreichisches Institut's Bebulin VH Immuno is a vapor-heated biologic containing coagulation Factors IX, II (Prothrombin), and X (Stuart Prower), along with low amounts of Factor VII and heparin. The approved labeling indicates that clinical studies have not demonstrated benefits for treating deficiencies other than Factor IX deficiency (搜索).