This approval is great news for people in Europe with haemophilia A
with inhibitors to factor VIII.
The bleeding episodes are treated with factor replacement therapy with either factor VIII for haemophilia A
and factor IX for haemophilia B or with cryoprecipitate or fresh frozen plasma.
Healthcare company Swedish Orphan Biovitrum AB (Sobi) reported on Thursday the receipt of approval from the Saudi Food & Drug Authority (SFDA) for Elocta to treat haemophilia A
in the Kingdom of Saudi Arabia.
prophylaxis of bleeding in patients with haemophilia A
and can be used for all age groups.
While this patient was discovered to have haemophilia A
, similar reports have been documented in patients with haemophilia B.
Factor IX inhibitors are far less common (occurring in 2 - 3% of boys with haemophilia) B than haemophilia A
, but they are accompanied by the occurrence of anaphylaxis or severe allergic reactions to any factor IX - containing product.
Hay CR, 011ier W, Pepper L, Cumming A, Keeney S, Goodeve AC, Colvin BT, Hill FG, Preston FE, Peake IR: HLA class H profile: A weak determinant of factor VIII inhibitor development in severe haemophilia A
4] Kar A et al studied 1467 patients from Maharashtra and found the ratio of haemophilia A
to haemophilia B patients was 4.
M2 EQUITYBITES-June 28, 2016-Sobi's Elocta receives approval in Switzerland for treatment of Haemophilia A
M2 PHARMA-June 28, 2016-Sobi's Elocta receives approval in Switzerland for treatment of Haemophilia A
The European Commission (EC) has approved Elocta (rFVIIIFc) for the treatment of haemophilia A
in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway.
and B are rare inherited bleeding disorders characterized in the most severe form by spontaneous bleeding into joint and muscles associated with invalidating arthropathy, as well as by more serious bleeds, namely intracranial haemorrhage (1).
Stonebreaker et al "A study of variations in the reported haemophilia A
prevalence around the world" Haemophilia 2010.
ELOCTATE and ALPROLIX are indicated for treatment of haemophilia A
and B, respectively and generated revenue of USD640m during last year ending 31 March 2016.
Swedish Orphan Biovitrum AB (publ) (Sobi) has received orphan drug designation in Switzerland for its long acting haemophilia drug candidate Elocta (rFVIIIFc) developed for the treatment of haemophilia A