Drugs firm moves a step closer to launch
Borders-based drugs firm Kyowa Kirin International (KKI) – formerly Prostrakan – has moved a major step closer to the European-wide launch of a product aimed at tackling a painful musculoskeletal condition.
The Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s scientific committee, said it has adopted a “positive opinion” recommending the conditional authorisation for marketing of its burosumab antibody for the treatment of a condition called X-linked hypophosphatemia (XLH).
If the agency now accepts the CHMP’S recommendations it would clear the way for KKI to start European launches of burosumab next year.
Dr Tom Stratford, president and chief executive of Galashiels-based KKI, said: “We are fully committed to improving the lives of the many young people across Europe who are living with XLH and 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 condition.”
The CHMP’S opinion will be referred to the European Commission, for a final decision on the grant of a conditional marketing authorisation.
The decision is expected in the first quarter of 2018 and will apply to all 28 countries of the European Union, plus Norway, Iceland and Liechtenstein.
Prostrakan rebranded as KKI after being acquired by Tokyo-based Kyowa Hakko Kirin in 2011.