Saudi FDA approves Sobi’s Alprolix for the treatment of haemophilia B

Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix (eftrenonacog alfa), for the treatment of haemophilia B.

Alprolix is the first extended half-life and recombinant factor IX Fc fusion protein therapy approved for the treatment of haemophilia B in Saudi Arabia.

“We are very pleased Alprolix is now approved in Saudi Arabia, which will enable physicians to offer their patients with haemophilia B a wider range of treatment options and the opportunity to experience extended protection from bleeds”, says Ahmad Abu-Dahab, Regional Director Middle East & Turkey. “We will now focus on ensuring timely and sustainable access to treatment across the country”.

Alprolix is indicated for treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) and it can be used for all age groups.

The Saudi Arabia approval was based on data from the phase 3 clinical studies B-LONG, which demonstrated the efficacy, safety and pharmacokinetics of eftrenonacog alfa in previously treated males 12 years of age and older with severe haemophilia B, and Kids B-LONG which demonstrated the efficacy and safety of eftrenonacog alfa in previously treated male children with haemophilia B under 12 years of age.