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Details:
CRYSVITA (burosumab) is a recombinant fully human monoclonal antibody that binds to and inhibits the activity of FGF23.2 CRYSVITA blocks the action of FGF23, which is produced in excess in TIO, restoring phosphate homeostasis.
Lead Product(s): Burosumab
Therapeutic Area: Musculoskeletal Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2022
Details:
Crysvita (burosumab) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23. Crysvita is designed to bind to and thereby inhibit the biological activity of FGF23.
Lead Product(s): Burosumab
Therapeutic Area: Rare Diseases and Disorders Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Divestment July 14, 2022
Details:
CRYSVITA (burosumab) was created and developed by Kyowa Kirin and is a recombinant fully human monoclonal antibody that binds to and inhibits the activity of FGF23.2 CRYSVITA blocks the action of FGF23, restoring phosphate homeostasis.
Lead Product(s): Burosumab
Therapeutic Area: Genetic Disease Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Crysvita® (burosumab-twza) is a fibroblast growth factor 23 (FGF23)-blocking antibody indicated for the treatment of X-linked hypophosphatemia and FGF23-related hypophosphatemia.
Lead Product(s): Burosumab
Therapeutic Area: Genetic Disease Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Ultragenyx Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2021
Details:
The Committee indicated that, if a patient is receiving a stable dose of Crysvita (burosumab), their treating physician can then recommend that administration be performed by the patient or their carer following training.
Lead Product(s): Burosumab
Therapeutic Area: Genetic Disease Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
CRYSVITA, created by Kyowa Kirin, is a recombinant fully human monoclonal IgG1 antibody against the FGF23. More people in Europe are now eligible for treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of XLH.
Lead Product(s): Burosumab
Therapeutic Area: Genetic Disease Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2020
Details:
The European Commission has already granted a conditional marketing authorisation for CRYSVITA for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.
Lead Product(s): Burosumab
Therapeutic Area: Genetic Disease Product Name: Crysvita
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
The sBLA package includes data from two single-arm Phase 2 studies including 14 adult patients conducted by Ultragenyx in the U.S. and 13 adult patients conducted by Kyowa Kirin in Japan.
Lead Product(s): Burosumab
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2020
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