BORDERS-based pharmaceuticals firm Kyowa Kirin International is seeking regulatory clearance to sell a new drug to treat the most common heritable form of the soft bone condition known as rickets.
The company, formerly called ProStrakan, has submitted an application to market the KRN23 treatment for X-linked hypophosphatemia in European Union countries to the European Medicines Agency.
“X-linked hypophosphatemia is a debilitating condition which causes long term pain and distress among sufferers and for which there are no currently approved treatments that target the underlying cause,” said Dr. Tom Stratford, chief executive of KKI.
The company is developing KRN23 with California-based Ultragenyx Pharmaceutical, which noted positive results from multiple studies in paediatric and adult patients with XLH.
The partners said the treatment has been designed to help increase the production of vitamin D, which enhances the absorption of phosphate and calcium. XLH is characterised by inadequate mineralisation of bone.
They expect to get an opinion on the application to the treatment from the EU’s Committee for Medicinal Products for Human Use in the second half of 2017
KRN23 is also being developed for tumour-induced osteomalacia, which can lead to fractures, bone and muscle pain and muscle weakness.
ProStrakan was rebranded as KKI in April to reflect the international image of its Japanese parent company, Kyowa Hakko Kirin, which bought the firm in 2011.
Mr Stratford’s father, Harry, co-founded ProStrakan in 1995.
KKI employs 150 people in Galashiels.
Kyowa Hakko Kirin described KKI as a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in Europe and the United States.
KKI and Ultragenyx plan to file an application with the Food and Drug Administration later this year covering the sale of KRN23 in the USA.
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