Ultragenyx, Kyowa Kirin Announce FDA Acceptance for Supplemental Biologics License

Ultragenyx Pharmaceutical (NASDAQ:RARE) and Kyowa Kirin announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Crysvita for the treatment of tumor-induced osteomalacia.

As quoted in the press release:

“We appreciate the FDA’s collaboration in evaluating the data, and as a result, we are another step closer to bringing the first treatment to patients with this devastating disease in the setting of an unresectable tumor,” said Camille L. Bedrosian, M.D., Chief Medical Officer of Ultragenyx. “We look forward to continuing to work closely with the FDA with the goal of bringing Crysvita to patients with TIO as quickly as possible.”

Click here to read the full press release.