The Swiss Agency for Therapeutic Products, Swissmedic, has approved Sobi’s Alprolix (eftrenonacog alfa) for the treatment of haemophilia B.
Haemophilia is a genetic disorder that impairs the body's ability to clot the blood required to stop bleeding. It occurs in about one in 25,000 male births annually, and more rarely in females.
Alprolix is a recombinant factor IX Fc Fusion protein therapy and is indicated for on-demand, as well as prophylaxis treatment of previously treated haemophilia B patients.
Sobi haemophilia vice-president and medical therapeutic area head Krassimir Mitchev said: “The Swiss approval of Alprolix is an important milestone for the haemophilia community, offering the opportunity for people with haemophilia B to experience prolonged protection from bleeds.
“We will now focus on ensuring timely and sustainable access to Alprolix in Switzerland.”
According to the World Federation of Haemophilia estimates, approximately 28,000 people are currently diagnosed with haemophilia B worldwide.
People with haemophilia B experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages.
Alprolix has been developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1.
It is currently approved for the treatment of haemophilia B in the EU, Iceland, Liechtenstein and Norway, as well as the US, Canada, Japan, Australia, New Zealand and other countries.