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The European Commission has granted marketing authorisation for Afstyla [ recombinant human coagulation Factor VIII, single chain ] for children and adults with haemophilia A.
Afstyla is the first and only single-chain product for haemophilia A. It is specifically designed for protection from bleeds with two or three times weekly dosing and low unit consumption at both dosing regimens.
In clinical trials, Afstyla has demonstrated a strong safety profile with no inhibitors observed in previously treated patients undergoing prophylaxis.

Afstyla is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A ( congenital factor VIII deficiency ).
Afstyla can be used for all age groups.

Primarily affecting males, haemophilia A is a congenital bleeding disorder characterised by deficient or defective factor VIII. People with haemophilia A may experience prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.
According to the World Federation of Hemophilia, about 1 in 10,000 people are born with haemophilia, the majority of whom have haemophilia A.

Afstyla ( also known as rVIII-Single Chain ) for haemophilia A is a recombinant single-chain Factor VIII specifically designed for greater molecular stability and longer duration of action through strong affinity to von Willebrand factor ( VWF ).
Afstyla uses a covalent bond that forms one structural entity, a single polypeptide-chain, to improve the stability of Factor VIII and provide Factor VIII activity with the option of twice weekly dosing.
Regulatory submissions for Afstyla are based on results from the AFFINITY clinical development Program.
Data from AFFINITY were published in the American Society of Hematology’s publication Blood and data comparing the pharmacokinetics of Afstyla and Octocog alfa in patients with severe haemophilia A were recently published in The World Federation of Hemophilia’s journal Haemophilia. ( Xagena  )

Source: CSL Behring, 2017

XagenaMedicine2017