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Roche: priority review to emicizumab.

(CercleFinance.com) - Roche has announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adolescents and children with haemophilia A with factor VIII inhibitors.


Emicizumab would be used as a prophylactic (preventive) treatment, administered subcutaneously once a week, in adults, adolescents and children with this disease.

Factor VIII inhibitors limit treatment options and raise the risk of life-threatening bleeds and repeated bleeds, particularly in joints, that cause long-term damage.


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