Afstyla, a new preventive treatment for hemophilia A developed in Korea, has obtained a license from the Ministry of Food and Drug Safety.
The ministry said it recently approved CSL Behring’s Afstyla (ingredient: lonoctocog alfa) for treating children and adults with hemophilia A.
Afstyla is used for the prevention and suppression of hemorrhage, routine prevention of bleeding or reduction of bleeding frequency, and prevention before and after surgery. It is not used to treat patients with Von Willebrand Disease.
The company said Afstyla is the first and only single-chain treatment for hemophilia A, specially developed for long-term bleeding control with two- or three-times injections a week. When activated in the body, it shows the same effect as blood clotting Factor VIII.
The nod for Afstyla was based on the results of the AFFINITY studies, including two critical trials on pediatric, adolescent, and adult patients with hemophilia A, and one open-label, multi-center study that extended the existing trial.
The clinical trials found that patients treated with Afstyla had zero annualized spontaneous bleeding rate (AsBR) on average.
Sohn Ji-young, general manager of CSL Behring Korea, said the company is a global biotech firm that is leading innovative genetic recombination technology to save patients' lives and improve their quality of life. “Afstyla was developed in Korea and completed by CSL Behring,” she said.
The winning of approval from the food and drug safety ministry, after nods from FDA and European Medicines Agency, is meaningful in that the company could provide a new innovative treatment for Korean patients, she added.
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