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FDA approval

KKI secures US backing for rickets drug

Tom StratfordBorders drugs developer Kyowa Kirin International has secured US approval for its treatment of the skeletal disorder rickets.

The company, formerly known as ProStrakan, has teamed up with Ultragenyx Pharmaceutical to promote X-linked hypophosphatemia.

Approval from the US Food and Drug Administration is seen as another ‘watershed’ moment after the EU gave its backing at the end of last year.

Dr Tom Stratford, president and chief executive of KKI, said: “This is excellent news for people affected by XLH and their families.

“Coming close behind the granting of a European Marketing Authorisation for Crysvita in children, this means that even more patients who suffer from this often debilitating condition can benefit from this medicine.”

XLH affects children and adults. In children it causes rickets that leads to lower-extremity deformity, delayed growth and decreased height.  Adults with XLH have an increased risk of fractures.



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