EC grants marketing authorisation to Sobi’s Altuvoct for haemophilia A treatment
Betsy Goodfellow | June 19, 2024 | News story | Medical Communications | Altuvoct, EC, EMA, Haematology, haemophilia a, sobi
Sobi has announced that the European Commission (EC) has granted marketing authorisation for Altuvoct (efanesoctocog alfa) for the treatment and prevention of bleeds and perioperative prophylaxis in haemophilia A.
The drug is a ‘high-sustained factor VIII replacement therapy for all ages and any disease severity’, according to the company’s press release.
The EC has also endorsed the European Medicines Agency (EMA) recommendation to retain Altuvoct’s orphan drug designation, providing a ten-year period of market exclusivity.
The EMA’s recommendation considered the fact that once-weekly treatment with Altuvoct prophylaxis demonstrated a significantly reduced annual bleeding rate compared to existing factor VIII products, therefore constituting a clinically relevant advantage.
The drug was first approved by the US Food and Drug Administration (FDA) for use in the US in February 2023, previously granting it Orphan Drug designation in 2017, Fast Track designation in February 2021 and Breakthrough Therapy designation in May 2022.
Lydia Abad-Franch MBA, head of research, development and medical affairs and chief medical officer at Sobi, commented: “Today’s announcement marks a major step forward in haemophilia care, offering the potential to significantly improve treatment outcomes and quality of life. For the first time, factor VIII activity levels can be sustained for a significant part of the week with simplified once-weekly dosing. We are proud to work alongside the haemophilia community, as we lead the paradigm shift towards normal haemostasis and create new possibilities together.”
Betsy Goodfellow
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