Biogen Idec BIIB and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:
SOBI) today presented new findings for their long-lasting recombinant factor
IX candidate ALPROLIX^* for hemophilia B at the XXIV International Society on
Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, The Netherlands.
Three oral presentations showcase new data that reinforce the potential
safety, efficacy and pharmacokinetic profile of ALPROLIX. The data highlight
the consistency of results with ALPROLIX across patient types and favorable
physician ratings of its efficacy in treating acute bleeding episodes and
controlling bleeding during and after major surgery.
“ALPROLIX is the first product candidate in a new class of long-lasting
clotting factor therapies, and the data presented today support the potential
of the therapy to reduce the frequency of prophylactic infusions for patients
with hemophilia B,” said Glenn Pierce, M.D., Ph.D., senior vice president of
Global Medical Affairs and chief medical officer of Biogen Idec's hemophilia
therapeutic area. “These new data help to build the clinical profile of
ALPROLIX by increasing our understanding of its efficacy.”
Treatment of Bleeding
An evaluation of the treatment of acute bleeding episodes across the
prophylaxis and episodic (on-demand) treatment arms of the phase 3 B-LONG
study showed that more than 90% of bleeds were controlled with a single
injection of ALPROLIX and more than 97% were controlled with two or fewer
injections. These data were showcased in the e-poster presentation:
* Treatment of Bleeding Episodes in Subjects with Haemophilia B with the
Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase
3 B-LONG Study
Surgery Analysis
Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX
consistently controlled bleeding during and after 14 major surgeries in 12
patients with hemophilia B. Physicians reported high efficacy levels of
ALPROLIX during surgery, with hemostasis (the stoppage of bleeding) rated as
“excellent” for 13/14 surgeries and “good” for 1/14 surgeries. According to
investigator analyses, the results were comparable to that for similar
surgeries in people without hemophilia. These data were showcased in the
e-poster presentation:
* Long-Lasting Recombinant Factor IX Fc Fusion (rFIXFc) for Perioperative
Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study
Population Pharmacokinetics (PK) Analysis
Analysis of a population pharmacokinetics (popPK) model developed for ALPROLIX
demonstrated that the model accurately predicts peak and trough factor IX
activity levels achieved in the B-LONG clinical study at a variety of ALPROLIX
doses. These data were showcased in the e-poster presentation:
* Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine
Prophylaxis, Control of Bleeding and Perioperative Management for
Haemophilia B Patients
“These new data from the B-LONG study support the potential application of Fc
fusion technology in hemophilia,” said Birgitte Volck, M.D., Ph.D., senior
vice president development and chief medical officer of Sobi. “The results add
to the growing body of evidence supporting the potential efficacy and safety
of this long-lasting clotting factor candidate for the treatment of hemophilia
B.”
ALPROLIX Global Regulatory Status
A Biologics License Application (BLA) for Biogen Idec's long-lasting
hemophilia product candidate ALPROLIX is currently under review with the U.S.
Food and Drug Administration (FDA) for the treatment of hemophilia B.
Marketing Applications for ALPROLIX have been submitted in Canada and
Australia for the treatment of hemophilia B. Additional regulatory filings are
planned.
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