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Adynovi (rurioctocog alfa pegol), new medicine authorised for the Treatment and prevention of bleeding in patients with haemophilia A

Adynovi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII. It can be used in adults and children from 12 years of age.

Adynovi contains the active substance rurioctocog alfa pegol.

Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Adynovi, rurioctocog alfa pegol, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.

Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.

The European Medicines Agency decided that Adynovi’s benefits are greater than its risks and recommended that it be approved for use in the EU. Studies show that Adynovi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products. However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment. Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.

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