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News & Trends - Pharmaceuticals

Melbourne endocrinologist welcomes first medicine approved for XLH in 40 years

Health Industry Hub | September 15, 2021 |
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Pharma News: Kyowa Kirin Australia welcomes the Therapeutic Goods Administration (TGA) registration of Crysvita (burosumab).

Crysvita is indicated for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents, and children 1 year of age or older and the first medicine to address the underlying cause of XLH.

“Crysvita is the first new kind of medicine for the treatment of XLH in more than forty years, and the science shows that it actively targets the cause of the disease,” said General Manager of Kyowa Kirin Australia, Simon Dawson.

Dr Peter Simm, Paediatric Endocrinologist, The Royal Children’s Hospital, VIC, and Murdoch Children’s Research Institute and Department of Paediatrics, University of Melbourne, told Health Industry Hub “It is an exciting time in the management of children with rare bone conditions as there are many new therapeutics coming on line for a wide range of conditions.

“For patients with X linked hypophosphatemic rickets, previous therapy was far from ideal, being difficult to take (several doses per day of an unpleasant tasting phosphate supplement) and also did not target the key molecular issue in this condition, leading to ongoing issues with limb bowing, growth and bone pain. Crysvita is innovative in that it directly targets the molecule that is causing the rickets, with patients far preferring the fortnightly injections (for children) to taking multiple doses of phosphate each day. Studies have shown significant healing in rickets on Crysvita, including my own experience being reduced bone pain in many of my patients with significant improvements in their quality of life.”

While Crysvita was Food and Drug Administration (FDA) approved for the same indication back in 2018, Dr Simm believes that the local regulatory approvals, although delayed, are vigorous. “We are fortunate in Australia that the TGA carefully considers applications, with a thorough and robust process. By following these strict protocols, we know that when an agent is approved, it has been vigorously assessed and can therefore be prescribed by us, the clinicians, with confidence.”

It is estimated that there are fewer than 1300 Australians living with the condition. Kyowa Kirin Australia continues to support a large number of Australians – mainly children – living with XLH who commenced treatment with Crysvita on compassionate grounds. Kyowa Kirin has been providing these individuals with access to the medicine at no cost under the TGA’s Special Access Scheme for unapproved medicines since 2019.

“The registration of Crysvita is a major milestone for our company, but our focus remains firmly on securing PBS reimbursement so that Australians living with XLH can be guaranteed long-term affordable access to this important medicine,” adeed Mr Dawson.

“Patients and physicians can be assured that Kyowa Kirin will continue to provide existing patients with compassionate access to Crysvita while a feasible long-term access solution is sought,” concluded Mr Dawson.

Crysvita is a recombinant human monoclonal IgG1 antibody that binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23), present in excess in XLH. Neutralisation of excessive FGF23 by Crysvita increases renal reabsorption of phosphate and the serum concentration of active Vitamin D (1, 25 dihydroxy-Vitamin D).


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