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GEN News Highlights : Jul 5, 2013
Biogen Idec, Sobi Cite Promising Phase III Results for Hemophilia A Drug
Biogen Idec and Sobi today presented data from the Phase III A-LONG trial showing that their long-lasting recombinant factor VIII candidate Eloctate for hemophilia A could potentially reduce the number of intravenous injections required by people with the disorder, while also showing efficacy in both controlling bleeding during and after surgery, as well as acute bleeding episodes.
The companies presented their data during five platform and oral presentations at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Amsterdam. Eloctate is the subject of a BLA filed with FDA, and a marketing application submitted to Australian authorities.
More than 87% of bleeds were controlled with a single injection of Eloctate, while more than 97% of were controlled with two or fewer injections, according to A-LONG results focused on treatment of acute bleeding episodes across the study’s prophylaxis and episodic (on demand) treatment arms.
The companies said A-LONG results also showed that, despite inherent patient-to-patient differences in thrombin generation activity, the combination of Eloctate and Baxter’s Advate® [antihemophilic factor (recombinant), plasma/albumin-free method] showed equivalent thrombin generation potential post-infusion. Eloctate also showed prolonged thrombin generation activity relative to Advate, correlating with pharmacokinetic data observed in patients, Biogen Idec and Sobi added.
However, Phase III results also showed that FVIII activity seen for Eloctate—measured by clotting time at 72 hours after dosing—was a mean clotting time of 1,238 seconds, compared with a mean clotting time of 1,213 seconds for Advate at 48 hours after dosing. Those results came from a rotation thromboelastometry analysis conducted on 44 patients treated with Elocate from 13 A-LONG study sites.
A-LONG results also showed Eloctate consistently controlled bleeding during and after nine major surgeries in nine patients with hemophilia A, by showing high efficacy during surgery, with hemostasis rated as “excellent” for eight of the nine surgeries and "good" for the ninth. According to the companies, the results were comparable to that for similar surgeries in people without hemophilia.
At ISTH, Baxter presented data showing Advate’s effect on "peaks" when patients had the highest factor levels in the first hours after infusion—rather than the traditional "troughs," representing lowest activity levels. Baxter’s analysis showed what it termed a "potentially important" relationship between higher peak values, plus time spent above 30% and 40% FVIII levels constituting the "hemostatically effective" nonhemophilic FVIII range—and efficacy for prophylaxis in hemophilia A patients.
By monitoring how long the factor remains active in the body, clinicians could design individual dosing regimens to reduce bleed frequency, Baxter said in a statement.
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