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KRN23 Received Breakthrough Therapy Designation from USFDA

 

Clinical courses

Kyowa Hakko Kirin Co., Ltd. announced KRN23, an investigational recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast growth factor 23(FGF23), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of X-linked hypophosphatemia (XLH) in pediatric patients one year of age and older. Kyowa Hakko Kirin and Ultragenyx entered into a collaboration and license agreement in August 2013 to develop and commercialize KRN23.

“We are excited to hear this great news.” said, Masashi Miyamoto, Ph.D., Director of Strategic Product Portfolio Department of Kyowa Hakko Kirin.”We will keep on makingeffort to develop the antibody with Ultragenyx to contribute to the patients with such life-long devastating disease.”

This Breakthrough Therapy Designation is based on interim 40-week data from the first 36 patients enrolled in the ongoing pediatric Phase 2 study of KRN23 for the treatment of XLH. In addition to the ongoing Phase 2 study, Ultragenyx plans to initiate a Phase 3 study of KRN23 in pediatric patients with XLH in mid-2016 by collaborating with Kyowa Hakko Kirin. A Phase 3 program of KRN23 in adult patients with XLH is ongoing.

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