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Sobi receives Swiss approval for Alprolix, a treatment for haemophilia B.

M2 EQUITYBITES-October 28, 2016-Sobi receives Swiss approval for Alprolix, a treatment for haemophilia B

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Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI), a specialty healthcare company dedicated to rare diseases, reported on Friday that it has received approval from the Swiss Agency for Therapeutic Products, Swissmedic, for Alprolix (eftrenonacog alfa), which is indicated for both on-demand and prophylaxis treatment of previously treated haemophilia B patients.

According to Sobi, Alprolix is the only recombinant factor IX Fc Fusion protein therapy approved in Switzerland for the treatment of haemophilia B, a rare, genetic disorder in which the ability of a person's blood to clot is impaired.

Alprolix has been developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body. For initiation of prophylaxis, one dose of Alprolix every seven days or every 10 days can be administered, with the ability to adjust the dosing interval based on individual response.

Haemophilia B is said to occur in about one in 25,000 male births annually, but more rarely in females. The World Federation of Haemophilia reportedly estimates that approximately 28,000 people are currently diagnosed with haemophilia B worldwide.

The company added that Alprolix 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.

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Publication:M2 EquityBites (EQB)
Date:Oct 28, 2016
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