Shire scores European approval for Adynovi in haemophilia A
pharmafile | January 15, 2018 | News story | Sales and Marketing | Adynovi, Europe, European Commission, Shire, haemophilia, haemophilia a, pharma
Shire has revealed that the European Commission has approved Adynovi (antihaemophilic factor (recombinant), PEGylated) for on-demand and prophylactic use in adult patients with haemophilia A.
Adynovi, approved as Adynovate in the US, Japan, Canada and Colombia, is an extended half-life recombinant factor VIII (rFVIII) treatment built on Advate, and is designed to extend the time between treatments by lasting longer in the blood compared to unmodified antihaemophilic factor. It is to be taken twice weekly.
The decision to approve the treatment was based on data derived from three Phase 3 trials investigating its efficacy in patients aged under 12, between 12 and 65, and in those with severe forms of the disease undergoing surgery.
Haemophilia A is caused by a lack of proper clotting factor VIII in the blood and causes longer-than-normal bleeding. It is estimated that around 150,000 suffer from the condition worldwide, with 75% of this number lacking adequate access to treatment.
“The European approval of Adynovi is an important milestone in our continued commitment to provide new treatment options for patients living with haemophilia A,” commented Dr Peter Foertig, Global Head Hematology Medical Affairs at Shire. “We believe that the twice-weekly prophylactic dosing, as well as the on-demand control of bleeding, offered by Adynovi will bring us closer to our goal of improving and personalising disease management for haemophilia A patients in Europe.”
Matt Fellows
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