KKI secures regulatory backing

Rickets treatment milestone for Borders firm

Tom StratfordA Borders drugs company is marking a significant milestone after the first of a promised pipeline of products from its parent secured regulatory approval.

Galashiels-based Kyowa Kirin International (formerly ProStrakan) will market Burosumab, a treatment for X-linked hypophosphatemia (XLH), commonly known as rickets.

It is a progressive musculoskeletal disorder which restricts growth. It was once prevalent in Britain and continues to blight adolescent children around the world. 

KKI’s parent company, Kyowa Hakko Kirin, with its development partner Ultragenyx, won backing for the drug from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s (EMA) scientific committee. It paves the way for the treatment to be distributed across Europe.

The CHMP’s opinion is now being referred to the European Commission (EC), for a final decision on the grant of a conditional marketing authorisation.

The decision of the EC is expected in the first quarter of 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein. The conditional authorisation requires fulfilment of specific obligations related to the completion of ongoing clinical studies of burosumab in paediatric patients.  

Tom Stratford (pictured), president and chief executive of Kyowa Kirin International, said: “At Kyowa Kirin International we are fully committed to improving the lives of the many young people across Europe who are living with XLH.

“We welcome the CHMP’s opinion which takes us one step closer to launching Burosumab across Europe as the first targeted treatment with the potential to address this often painful and debilitating musculoskeletal condition.

Kyowa Hakko Kirin acquired ProStrakan, a speciality pharmaceuticals business, in 2011, delisting the company and promising to deliver a number of products for distribution.

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