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.
Ultragenyx is a biopharmaceutical company committed to bringing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved medicines and treatment candidates aimed at addressing diseases with high unmet medical need and clear biology, for which there are typically no approved therapies treating the underlying disease.
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.
Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx’s expectations and projections regarding its future operating results and financial performance, anticipated cost or expense reductions, the timing, progress and plans for its clinical programs and clinical studies, future regulatory interactions, and the components and timing of regulatory submissions are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, collaboration with third parties, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the effects from the COVID-19 pandemic on the company’s commercialization activities, business and operating results, risks related to reliance on third party partners to conduct certain activities on the company’s behalf, smaller than anticipated market opportunities for the company’s products and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company’s future operating results and financial performance, and the availability or commercial potential of Ultragenyx’s products and drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 3, 2021, and its subsequent periodic reports filed with the Securities and Exchange Commission.
Ultragenyx Pharmaceutical Inc.
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