Business
Ultragenyx Launches Evkeeza® (evinacumab for injection) in Canada for the Treatment of Homozygous Familial Hypercholesterolemia (HoFH)
Evkeeza is a first-in-class medicine approved by Health Canada, the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an
About this update from Ultragenyx Pharmaceutical Inc.
[{"type":"text","content":"Evkeeza is a first-in-class medicine approved by Health Canada, the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an ultrarare, inherited form of high cholesterol\nTORONTO, Sept. 25, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare genetic diseases, today announced the approval of Evkeeza® (evinacumab) in Canada. Evkeeza® was approved by Health Canada as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia (HoFH) and will be commercially available in Canada effective 25-November-2023. Evkeeza is a first-of-its-kind treatment for HoFH and is the first monoclonal antibody inhibiting the angiopoietin-like 3 protein (ANGPTL3). Evkeeza is delivered via 60-minute intravenous infusion every 4 weeks. The treatment is now available to prescribe for patients with HoFH in Canada. “The approval and launch of Evkeeza in Canada for the treatment of homozygous familial hypercholesterolemia exemplifies our commitment to bring innovative therapies for people living with rare and ultrarare genetic diseases,” said Monty Keast, Vice President and General Manager at Ultragenyx Canada. “We look forward to working collaboratively with health care providers, the HoFH patient community and payers from across the country to make this potentially life-changing therapy accessible to people living with this serious disease.” “HoFH is a severe atherosclerotic disease associated with premature cardiovascular morbidity, which most often does not adequately respond to cholesterol-lowering treatment currently available,” said Prof. Daniel Gaudet, Lipidologist and Director of the Severe Lipid Disorders Unit at the Community Genetic Medicine Center, Department of Medicine, Université de Montréal. “Our experience in recent years in phase 2 and 3 clinical studies, clearly demonstrates that in combination with diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies, evinacumab represents an effective option to substantially lower the levels of LDL-cholesterol and other atherogenic lipoproteins in HoFH patients.” About H...