Burosumab

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Burosumab (INN, trade name Crysvita) known as KRN23 is a human monoclonal antibody designed for the treatment of X-linked hypophosphatemia.[1][2][3] Burosumab was approved by the FDA for its intended purpose, in patients aged 1 year and older, on 17 April 2018.[4] The FDA approval fell under both the breakthrough therapy and orphan drug designations.[4]

This drug was developed by Ultragenyx and is in a collaborative license agreement with Kyowa Hakko Kirin.[5]

While burosumab is effective for the treatment of X-linked hypophosphatemia, the National Institute for Health and Care Excellence in England and Wales initially raised concerns regarding the incremental cost-effectiveness of the new treatment[6] but the drug is available through a simple discount scheme. [7]

References

  1. Statement On A Nonproprietary Name Adopted By The USAN Council - Burosumab, American Medical Association.[permanent dead link]
  2. World Health Organization (2016). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 115" (PDF). WHO Drug Information. 30 (2): 255.
  3. "Burosumab (KRN23) for X-Linked Hypophosphatemia (XLH)" (PDF). n.d. Retrieved 2018-04-18.
  4. 4.0 4.1 "FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia" (Press release). FDA. 17 April 2018.
  5. "Collaboration with Ultragenyx to Develop and Commercialize KRN23 for X-linked Hypophosphatemia" (Press release). Kyowa Kirin. 4 September 2013. Retrieved 2018-04-17.
  6. "U.K. cost watchdogs turn away rare disease med Crysvita".
  7. "1 Recommendations | Burosumab for treating X-linked hypophosphataemia in children and young people | Guidance | NICE". www.nice.org.uk. Retrieved 2019-06-14.

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