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EU approval for self-administered Crysvita pharmatimes
July 21, 2021
Kyowa Kirin has received approval in the EU for the self-administration option of its X-linked hypophosphataemia (XLH) treatment Crysvita.
Positive CHMP opinion for self-administered Crysvita pharmatimes
May 11, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the rare metabolic bone disease X-linked hypophosphataemia (XLH).
CHMP backs expanding scope of Kyowa Kirin's Crysvita pharmatimes
July 28, 2020
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding approval of Kyowa Kirin's Crysvita (burosumab) to include older adolescents and adults living with X-linked hypophosphataemia (XLH).
FDA Approves Therapy for Disease that Causes Low Phosphate Blood Levels, Bone Softening americanpharmaceuticalreview
June 30, 2020
The U.S. Food and Drug Administration (FDA) has approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO).
US FDA grants approval to Ultragenyx Pharmaceutical for Crysvita expresspharma
June 22, 2020
The drug has been approved to treat patients with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones.
XLH patients to get routine access to first new therapy in 30 years pharmatimes
October 11, 2018
For the first time in more than 30 years children and young adults in England and Wales with the rare bone disorder XLH will have access to a new treatment option via the NHS.
NICE u-turn approves funding for rare disease therapy Crysvita pharmatimes
September 14, 2018
The National Institute for Health and Care Excellence (NICE) has changed its position on NHS funding for Kyowa Kirin International’s Crysvita...
Rare disease therapy Crysvita to be barred from NHS pharmatimes
June 21, 2018
Children and young people with X-linked hypophosphataemia (XLH) are unlikely to get routine access to Kyowa Kirin’s Crysvita on the NHS.
Crysvita Study Met Primary Endpoint americanpharmaceuticalreview
May 18, 2018
Ultragenyx Pharmaceutical and Kyowa Kirin announced the Phase 3 study of Crysvita (burosumab) met its primary endpoint demonstrating that Crysvita was superior to oral phosphate and active vitamin D (conventional therapy)
FDA Approves First Therapy for Rare Inherited Form of Rickets, X-Linked Hypophosphatemia americanpharmaceuticalreview
April 19, 2018
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets.