MEDIA ADVISORY: Ultragenyx Canada Announces Health Canada Approval of a Second Indication for Crysvita™ (Burosumab Injection) for the Treatment of Tumour Induced Osteomalacia in Adults
September 07, 2021 at 08:00 AM EDT
OTTAWA, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, today announced that Crysvita™ (Burosumab Injection) has been approved by Health Canada for the treatment of Tumour Induced Osteomalacia (TIO) in adults. Crysvita is also approved for the treatment of X-Linked Hypophosphatemia.
TIO is a rare disease that is characterized by the development of tumours that cause weakened and softened bones. The tumours associated with TIO release a protein known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
INDICATION FOR TUMOUR INDUCED OSTEOMALACIA (TIO)
CRYSVITA (Burosumab Injection) is indicated for the treatment of fibroblast growth factor 23 (FGF23)–related hypophosphatemia in tumour-induced osteomalacia (TIO) associated with tumours that cannot be curatively resected or localized in adult patients.
Treatment should be initiated and monitored by a health professional experienced in the management of patients with metabolic bone diseases.
Safety and efficacy in pediatric and geriatric populations have not been established.
For Important Safety Information, please consult the Crysvita Product Monograph here. The Product Monograph is also available by calling 1-833-388-5872.
About Ultragenyx Pharmaceutical Inc.
The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.
A quote from Dr. Aliya Khan, Professor of Clinical Medicine, Divisions of Endocrinology and Metabolism and Geriatrics; Director of Fellowship in Metabolic Bone Disease and Director of the Calcium Disorders Clinic at McMaster University is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/417b422c-d325-4c9d-94bb-26488778a692
Dr. Aliya Khan Quote A quote from Dr. Aliya Khan, Professor of Clinical Medicine, Divisions of Endocrinology and Metabolism and Geriatrics; Director of Fellowship in Metabolic Bone Disease and Director of the Calcium Disorders Clinic at McMaster University.