Japanese pharma Kyowa Kirin has been granted approval from the European Commission for Crysvita in older adolescents and adults with X-linked hypophosphataemia (XLH).
Crysvita (burosumab) is already approved in the EU for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.
The expanded approval for Crysvita is based on data from two phase III studies in adults with XLH as well in adults with XLH-associated osteomalacia (softening of the bones).
These studies found that treatment with Crysvita increased and maintained serum phosphate levels in the normal range, helped to heal pseudofractures and fractures related to osteomalacia and improved osteomalacia.
Additional endpoints demonstrated that patients had less pain and stiffness and their physical functioning and mobility also improved with time.
“Today’s decision from the European Commission is a significant milestone for the management of XLH, a progressive and life-long disease that profoundly impacts the lives of both children and adults,” said Abdul Mullick, president of Kyowa Kirin International.
With this approval, older adolescents and adults with XLH will also be able to benefit from treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of this disease. We now will focus on ensuring access for as many people as possible in this expanded group of eligible patients,” he added.
XLH is a progressive disease that causes lower limb deformities, stunted growth and joint pain. Other symptoms, including dental abscesses, osteoarthritis, enthesopathy and hearing loss can also develop during adulthood.