Ultragenyx and Kyowa Kirin Announce Health Canada Approval of Crysvita

Ultragenyx Pharmaceutical (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, Kyowa Hakko Kirin and Kyowa Kirin International today announced that Crysvita™ (burosumab injection) has been approved by Health Canada for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients one year of age and older.

As quoted in the press release:

“This approval of Crysvita offers Canadian patients living with XLH the first treatment option that targets the underlying cause of this rare and debilitating disease,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “Crysvita is now approved in the United States, Europe and Canada, all within one year, and Ultragenyx and Kyowa Kirin are pursuing regulatory filings in other countries to ensure that Crysvita is available to patients with XLH around the world as quickly as possible.”

“With this approval for Crysvita, now there is an entirely new option for XLH patients in Canada,” said Toshifumi Mikayama, Ph.D., Director of the Board, and Senior Managing Executive Officer of Kyowa Hakko Kirin. “I am pleased that Crysvita will be able to make a major contribution to improving the lives of XLH patients in Canada and we are committed to working with those affected by this hereditary and lifelong disease in the world.”

“Burosumab is the first treatment to address the fundamental problem in this disease – renal phosphate wasting,” said Leanne Ward, MD, a Professor of Pediatrics at the University of Ottawa, where she holds a Research Chair in Pediatric Bone Health. “With this therapy, administered every 2 to 4 weeks subcutaneously, we see sustained improvements in phosphate metabolism and skeletal mineralization. Additional efforts are now underway to understand the longer-term benefits and side effects.”

Click here to read the full press release.