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Promising Phase III Data Reported for Hemophilia Drug, Eloctate
Treatment requires fewer infusions than current therapies (November 13)
Positive results have been reported from a phase III study of an investigational recombinant factor VIII constant fragment (Fc) fusion protein candidate (Eloctate, Biogen Idec/Swedish Orphan Biovitrum AB) in patients with severe hemophilia A.
The results, published online in Blood, show that treatment may achieve effective prevention or reduction of bleeding episodes with one or two prophylactic infusions a week. Available therapies currently require prophylactic infusions two to three times per week or every other day, based on guidelines established by the Medical and Scientific Advisory Council of the National Hemophilia Foundation.
The A-LONG study evaluated Eloctate in 165 male subjects with severe hemophilia A aged 12 years and older. The subjects were randomly assigned to receive either individualized prophylactic therapy (every 3 to 5 days with individual pharmacokinetics-guided dosing adjustments) or weekly prophylactic therapy to reduce or prevent bleeding episodes. The trial also evaluated episodic dosing to treat bleeding episodes and to control bleeding during surgery.
The median annualized bleeding rates (ABRs), or the projected number of yearly bleeding episodes, were 1.6 in the individualized-treatment arm and 3.6 when Eloctate was administered once weekly.
Subjects in the episodic-dosing arm had an ABR of 33.6. Eloctate controlled more than 87% of bleeding episodes with a single infusion, and physicians rated the hemostatic response (i.e., the control and prevention of a bleeding episode) as excellent or good in all major surgeries (N = 9).
Eloctate was developed using Fc fusion technology, which employs a naturally occurring pathway that delays the breakdown of the immunoglobulin G1 (IgG1) protein in the body by recycling it back into the bloodstream. According to the drug’s developers, this technology prolongs the time Eloctate circulates in the body.
Source: Biogen Idec; November 13, 2013.