Questions & Answers
On 25 February 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Alprolix, intended for the treatment and prophylaxis of bleeding in patients with Haemophilia B. Alprolix was designated as an orphan medicinal product on 08 June 2007. The applicant for this medicinal product is Biogen Idec Ltd.
Alprolix will be available as 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU Powder and solvent for solution for injection. The active substance of Alprolix is eftrenonacog alfa, an antihaemorrhagic, blood coagulation factor IX, (ATC code: B02BD04). It works as replacement therapy and temporarily increases plasma levels of factor IX, helping to prevent and control bleeding.
The benefits with Alprolix are its ability to stop the bleeding when given on demand and prevent bleeding when used as routine prophylaxis or for surgical procedures. The most common side effects are headache, paresthesia oral and obstructive uropathy.
The full indication is: "the treatment and prophylaxis of bleeding in patients with Haemophilia B (congenital factor IX deficiency)". Alprolix can be used in all age groups. It is proposed that Alprolix be prescribed by physicians experienced in the treatment of Haemophilia B.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
|Name||Language||First published||Last updated|
|CHMP summary of opinion for Alprolix||(English only)||2016-02-26|
|INN or common name|
|Therapeutic area||Hemophilia B|
|Date opinion adopted||25/02/2016|
Biogen Idec Ltd
|Application type||Initial authorisation|