Posted by Michael Wonder on 12 Oct 2020
Alexion receives FDA approval for new advanced formulation of Ultomiris (ravulizumab-cwvz) with significantly reduced infusion time
12 October 2020 - New 100 mg/mL formulation will reduce infusion time by approximately 60 percent, lessening the burden on patients.
Alexion Pharmaceuticals today announced the U.S. FDA has approved Ultomiris (ravulizumab-cwvz) 100 mg/mL formulation for the treatment of adults with paroxysmal nocturnal haemoglobinuria and for atypical haemolytic uraemic syndrome to inhibit complement-mediated thrombotic microangiopathy for adult and paediatric (one month of age and older) patients.
Ultomiris 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60% compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. With Ultomiris 100 mg/mL, most patients will spend six hours or less a year receiving treatment.
