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Crysvita® (burosumab) now launched in the U.S. and Europe.

Crysvita® (burosumab) entered the commercial supply chain in Europe and the United States and booked its first sales to specialty pharmacies on April, 2018. It was approved for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients (in Europe, only for pediatric patients now). Crysvita® is the first prescription drug to address the excess FGF23 activity in XLH, the underlying cause of the disease, in the world.

What is XLH?

X-Linked hypophosphatemia (XLH) image

X-Linked hypophosphatemia (XLH) is a rare, hereditary, progressive and lifelong skeletal disorder caused by overexpression of phosphaturic hormone fibroblast growth factor 23 (FGF23). In XLH, reduced serum levels of phosphorus and vitamin D prevent adequate mineralization of bone, leading to skeletal abnormalities, impaired growth, and extreme pain. XLH is a rare disease occurring in one out of 20,000 people in the world. It is estimated that the number of XLH patients in children in Europe is about 3,000 and the patients in children and adults in the United States is about 15,000.

What kind of drug Crysvita® is?


A strategic product driving KHK's growth as a GSP is KRN23 (burosumab), which treats X-Linked hypophosphatemia (XLH). KRN23 is the first treatment to target the cause of the disease, by controlling excess FGF23. Kyowa Kirin discovered KRN23 — a recombinant fully human monoclonal IgG1 antibody — which effectively raises serum phosphorus level and maintains it within the normal range. Having proven safe and highly effective in clinical trials, KRN23 is attracting attention as a new treatment for this rare disease.

Development of overseas market

Kyowa Kirin has set a target to raise the overseas sales ratio of about 30% in 2017 to 50% in the future. Crysvita® will play an important role toward achieving the goal.

In Europe and the U.S., ways of marketing drugs have been increasingly changing. For this reason, changing or strengthening the sales structure accordingly holds the key. With the aim of placing Crysvita® on the market smoothly and launching it at full throttle, we have established a new professional structure called “Rare Disease Franchises”. As part of the above project, we initiated enlightening activities for XLH disease by opening the “XLH link,”( https://www.xlhlink.com/ ) a website in July 2017 for developing disease awareness of XLH and supporting patients.

Efforts are still required to enhance the value of pharmaceuticals further after they are launched. Thus, we accumulate clinical researches in collaboration with a wide array of divisions andproperly deliver the results to major healthcare facilities and professionals in respective countries, thereby spreading the value of the KYOWA KIRIN brand throughout the world.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

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