Shire has announced that its haemophilia A therapy Adynovi has received marketing authorisation from the European Commission.
The regulator has approved the drug for on-demand and prophylactic use among patients aged 12 years and older living with haemophilia A. Adynovi has been modified to last longer in the blood and potentially require less frequent injections than other unmodified therapies.
“Shire has received EU regulatory approval for Adynovi, allowing the drug to be used as a treatment for adults and adolescents with haemophilia A.“
Shire's new product builds on the proven benefits of Advate, a treatment used by haemophilia A patients worldwide for almost 15 years, and uses proprietary PEGylation technology from Nektar Therapeutics to extend the time between treatments and offer a twice-weekly dosing schedule.
This approval was based on positive data from three phase III clinical trials of patients with haemophilia A, during which the drug was able to demonstrate its safety and efficacy among adults and adolescents.
Dr Peter Foertig, global head of haematology medical affairs at Shire, said: "The European approval of Adynovi is an important milestone in our continued commitment to provide new treatment options for patients living with haemophilia A."
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