Kyowa Kirin Responds to NICE’s Publication of Appraisal Document for CRYSVITA
Kyowa Kirin is taking over commercialization duties for its rare disease drug Crysvita in North America and building out a new strategy to grow the $1 billion drug.
Strengthens balance sheet with non-dilutive capital at an attractive cost Competitive process results in the sale of 30% of the Ultragenyx royalty interest, subject to a 1.45x cap Proceeds to fund...
TOKYO--(BUSINESS WIRE)--Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that CRYSVITA® (burosumab) be approved for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.
NOVATO, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced that new data highlighting Crysvita®
Kyowa Kirin’s Crysvita (burosumab) has new long-term data showing ‘sustained’ benefits for adults living with the rare genetic metabolic bone disease X-linked hypophosphataemia (XLH).
TOKYO--(BUSINESS WIRE)--Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) today announced the publication of new data highlighting the sustained benefits of treatment with CRYSVITA® (burosumab) in adults with X-linked hypophosphataemia (XLH), a rare genetic metabolic bone disease. The data show that adults with XLH experience substantial pain, stiffness, fatigue and impairment in physical and ambulatory function. Treatment with CRYSVITA was associated with a significant improvement from baseline after 96 weeks.1
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 that Crysvita ™ (injection burosumab) had been approved by Health Canada for the treatment of oncogenic osteomalacia (Tumor Induced Osteomalacia, TIO) in adults. Crysvita is also approved for the treatment of X-linked hypophosphatemia.
Japanese pharma Kyowa Kirin has been granted approval from the European Commission for Crysvita in older adolescents and adults with X-linked hypophosphataemia (XLH).
Japanese pharma Kyowa Kirin has been granted approval from the European Commission for Crysvita in older adolescents and adults with X-linked hypophosphataemia (XLH).