Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita ™ (Burosumab injection) for the treatment of tumor-induced osteomalacia in adults
Quote from Dr Aliya Khan
A quote from Dr Aliya Khan, Professor of Clinical Medicine, Divisions of Endocrinology and Metabolism and Geriatrics; Director of the Fellowship in Metabolic Bone Disease and Director of the Calcium Disorders Clinic at McMaster University.
OTTAWA, Sep 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 the approval of Crysvita ™ (Burosumab Injection) by Health Canada for the treatment of tumor-induced osteomalacia (TIO) in adults. Crysvita is also approved for the treatment of X-linked hypophosphatemia.
ITI is a rare disease characterized by the development of tumors that cause the bones to weaken and soften. TIOs associated with TIO release a protein known as fibroblast growth factor 23 (FGF23) which lowers phosphate levels.
INDICATION OF TUMOR-INDUCED OSTEOMALACIA (TIO)
CRYSVITA (Burosumab Injection) is indicated for the treatment of Fibroblast Growth Factor 23 (FGF23) -related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with tumors that cannot be resected or localized. curative in adult patients.
Treatment should be started and supervised by a healthcare professional experienced in the management of patients with metabolic bone disease.
Safety and efficacy in pediatric and geriatric populations have not been established.
For important safety information please see 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 providing novel therapies to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved drugs and therapeutic candidates aimed at treating diseases with high medical need and clear biology, for which there are generally no approved therapies to treat the underlying disease.
The company is led by a management team experienced in the development and commercialization of treatments for rare diseases. Ultragenyx’s strategy is based on rapid and cost-effective drug development, with the aim of delivering safe and effective therapies to patients in the shortest possible time.
For more information about Ultragenyx, please visit the company’s website at: www.ultragenyx.com.
Except for historical information contained herein, matters set forth in this press release, including statements relating to Ultragenyx’s expectations and projections regarding its future operating and financial performance, cost reductions or anticipated expenses, the timing, progress and plans of 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, our collaboration with third parties, our future results, our performance or our achievements to differ. considerably of those expressed or sub understood by forward-looking statements. These risks and uncertainties include, among others, the effects of the COVID-19 pandemic on the marketing activities, activities and operating results of the company, risks related to dependence on third party partners to carry out certain activities on behalf of the company, market opportunities smaller than expected. for the Company’s product and product candidates, manufacturing risks, competition from other therapies or products, and other matters that could affect the adequacy of cash, cash equivalents and short-term investments to fund the operations, results of operations and future financial performance of the Company, and the availability or commercial potential of Ultragenyx’s products and drug candidates. Ultragenyx assumes no obligation to update or revise any forward-looking statements. For a more detailed description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Ultragenyx’s business 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 Pharmaceuticals Inc.
A quote from Dr Aliya Khan, Professor of Clinical Medicine, Divisions of Endocrinology and Metabolism and Geriatrics; The Director of the 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