Swedish Orphan Biovitrum announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Elocta (efmoroctocog alfa), a recombinant human factor VIII Fc-fusion protein with an extended half-life, for the treatment of haemophilia A.
Elocta is the first extended half-life and recombinant factor VIII Fc fusion protein therapy approved for the treatment of haemophilia A in Saudi Arabia.
“The approval of Elocta in Saudi Arabia is an important development for the haemophilia community in the Middle East and will enable physicians to offer their patients a wider range of treatment options,” says Ahmad Abu-Dahab, Regional Director Middle East, & Turkey.
“We will now focus on ensuring access to Elocta for people living with haemophilia A across other Middle Eastern states,” says Ebrahim Al-Hagiri, Regulatory & Patient Access Manager Middle East & Turkey. “This is a very important milestone to ensure that patients with haemophilia A have an early and sustainable access to this bleed prevention treatment.”
Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages.
The Saudi Arabia approval was based on data from Elocta’s pivotal, phase 3 A-LONG clinical study, which demonstrated the efficacy, safety and pharmacokinetics of efmoroctocog alfa in previously treated males 12 years of age and older with severe haemophilia A, and from the phase 3 Kids A-LONG clinical study, which demonstrated the efficacy and safety of efmoroctocog alfa in previously treated male children with haemophilia A under 12 years of age.