The Saudi Food and Drug Authority (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) clotting therapy Alprolix (eftrenonacog alfa) for the treatment of patients with haemophilia B in Saudi Arabia.
Developed using Fc fusion technology, Alprolix is an extended half-life and recombinant factor IX Fc fusion protein therapy designed to extend circulation in the body.
The drug is engineered with the fusion of factor IX to Fc portion of immunoglobulin G subclass 1 (IgG1) and is manufactured using a human cell line.
In addition to treatment, Alprolix is indicated for prophylaxis of bleeding in haemophilia B patients of any age group.
Sobi Middle East and Turkey regional director Ahmad Abu-Dahab said: “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.
“We will now focus on ensuring timely and sustainable access to treatment across the country.”
The SFDA approval is based on the results obtained during the Phase III B-LONG and Kids B-LONG clinical trials, which validated the efficacy, safety and pharmacokinetics of eftrenonacog alfa.
Sobi has collaborated with US-based biotechnology firm Bioverativ for the development and commercialisation of Alprolix.
While Sobi has final development and commercialisation rights in the Sobi territory, including Europe, North Africa, Russia and most Middle East countries, Bioverativ holds them for all other regions excluding the territory.
Alprolix is currently approved and marketed to treat haemophilia B in the EU, Iceland, Kuwait, Norway, Switzerland, the US, Canada, Japan, Australia, New Zealand and Brazil, among others.