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Mohammad Saffarioun, CEO of Aryogen Pharmed announced that recombinant coagulation factor VIII has obtained marketing authorization.
Mohammad Saffarioun, CEO of Aryogen Pharmed announced that recombinant coagulation factor VIII has obtained marketing authorization. He added that this conditional approval has been granted to this medicine with brand name Coageight based on primary outcome of ongoing clinical trials.
In the clinical research study which has been done in Shiraz, Mashhad, Isfahan, and Tehran over a period of two months, safety and efficacy of Coageight is tested on 50 participants with severe hemophilia A. The conditional authorization has been granted based on primary reports from ongoing surveys and it is estimated that the study will be finalized by the end of September and with complete results we are able to receive full authorization. In this study Coageight was compared to Eloctate – a recombinant coagulation factor from Swedish company Sobi – and no adverse effect was reported in the study arms (Coageight and Eloctate). Doctors responsible for the execution of the study have also recommended this medicine.