KRN23

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

Retrieved on: 
Thursday, June 18, 2020
Branches of biology, Musculoskeletal system, Growth factors, Anatomy, Vitamin D, Fibroblast growth factor 23, Bones, Fibroblast growth factor, Osteomalacia, Bone, Electrolyte, KRN23

The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.

Key Points: 
  • The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
  • "Treatment for TIO focuses on identifying and removing the tumor that causes the disease.
  • FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function.
  • When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).

Ultragenyx and Kyowa Kirin Announce FDA Acceptance and Priority Review Designation of Supplemental Biologics License Application for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)

Retrieved on: 
Thursday, February 27, 2020
Medical specialties, Monoclonal antibodies, Medicine, Health, Food and Drug Administration, Pharmaceuticals policy, Prescription Drug User Fee Act, Priority review, Fibroblast growth factor 23, Kirin, KRN23

The FDA has assigned priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020.

Key Points: 
  • The FDA has assigned priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020.
  • If approved, we believe Crysvita may also become a meaningful treatment option for many patients with TIO in the U.S.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23.
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.

Ultragenyx and Kyowa Kirin Announce Submission of Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) for Tumor-Induced Osteomalacia (TIO)

Retrieved on: 
Monday, January 13, 2020
Medical specialties, Branches of biology, Monoclonal antibodies, Biology, Fibroblast growth factor 23, Vitamin D, Kirin, KRN23

The companies expect to hear back from FDA on submission acceptance and review designation in February 2020.

Key Points: 
  • The companies expect to hear back from FDA on submission acceptance and review designation in February 2020.
  • In both studies, Crysvita was associated with increases in serum phosphorus and serum 1,25-dihydroxyvitamin D levels.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23.
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.

Ultragenyx Announces Sale of Future European Royalties on Crysvita® (burosumab) for $320 Million to Royalty Pharma

Retrieved on: 
Wednesday, December 18, 2019
Life sciences, Biotechnology, Articles, Monoclonal antibodies, Fibroblast growth factor 23, Biopharmaceutical, Royalty payment, KRN23

Once the threshold amount has been met, the EU, UK, and Switzerland royalty payments will revert back to Ultragenyx.

Key Points: 
  • Once the threshold amount has been met, the EU, UK, and Switzerland royalty payments will revert back to Ultragenyx.
  • Royalty Pharma adds a high quality asset that is an excellent addition to our diversified portfolio of leading biopharmaceutical royalties.
  • Wood Capital Advisors LLC acted as financial advisors and Gibson, Dunn & Crutcher LLP acted as legal advisor to Ultragenyx on the transaction.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone FGF23.

Ultragenyx and Kyowa Kirin Announce U.S. FDA Approves Label Update for Crysvita® (burosumab) for the Treatment of X-Linked Hypophosphatemia (XLH)

Retrieved on: 
Monday, September 30, 2019
Monoclonal antibodies, KRN23, X-linked hypophosphatemia, Branches of biology, Fibroblast growth factor 23, Burosumab, Kirin

The 64-week safety profile was similar to that observed at 40 weeks and in other Crysvita pediatric XLH studies.

Key Points: 
  • The 64-week safety profile was similar to that observed at 40 weeks and in other Crysvita pediatric XLH studies.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23).
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.
  • Crysvita is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.

Ultragenyx and Kyowa Kirin Announce Intent to Submit Supplemental Biologics License Application to U.S. FDA for Crysvita® (burosumab) in Tumor-Induced Osteomalacia (TIO)

Retrieved on: 
Tuesday, September 10, 2019
Monoclonal antibodies, Biology, Life sciences, Branches of biology, Kyowa Hakko Kirin, Kirin, KRN23, Fibroblast growth factor 23

The decision to submit follows the completion of a pre-sBLA meeting with the FDA and agreement on the filing package.

Key Points: 
  • The decision to submit follows the completion of a pre-sBLA meeting with the FDA and agreement on the filing package.
  • Bone scans also demonstrated an increase in healed fractures and decrease in new fractures during Crysvita treatment.
  • Crysvita (burosumab-twza) is a recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone FGF23.
  • Kyowa Kirin and Ultragenyx have been collaborating in the development and commercialization of Crysvita globally based on the collaboration and license agreement between the parties.