Page 18 - Roche Hemlibra Non-inhibitors - Product Monograph

6. OVERVIEW OF HEMLIBRA®(EMICIZUMAB)

HEMLIBRA (Emicizumab) is a humanized bispecific antibody that recognizes FIX/IXa and FX/Xa.
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It accelerates FIXa-catalyzed FX activation by bridging FIXa and FX in a manner similar to FVIIIa
(Kitazawa T, et al. 2017).

FIXa-catalyzed FX activation is a crucial step in the blood clotting process and is facilitated by
FVIII which links FIXa and FX together. However, this process is hampered due to FVIII deficiency
in patients with hemophilia A (Kitazawa T et al. 2017). Thus, HEMLIBRA helps to restore the
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natural hemostatic process in people with hemophilia A (HEMLIBRA SmPC). However,
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HEMLIBRA has no structural relationship or sequence homology to FVIII and does not induce
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or enhance the development of direct inhibitors to FVIII. Thus, HEMLIBRA can be used in
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hemophilia A patients with and without inhibitors.

Apart from the novel mechanism of action, HEMLIBRA has improved efficacy over the standard
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of care FVIII concentrates. HEMLIBRA is administered subcutaneously, obviating the need for
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venous access. Due to high subcutaneous bioavailability, it has the potential to significantly
change the treatment of patients with hemophilia A. Phase III randomized controlled trials
confirm the favorable PK properties of HEMLIBRA . It also allows for weekly (QW), every 2
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weeks (Q2W), or every 4 weeks (Q4W) dosing of HEMLIBRA , which is an advantage over the
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frequent dosing of intravenous FVIII therapies. Thus, HEMLIBRA is expected to substantially
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improve upon current treatment options, allowing for a more convenient mode of
administration and addressing the major issues with current prophylactic intravenous
regimens, while fulfilling a strong medical need.

Clinical trials suggest that patients with severe hemophilia A should be given the sustained
protection of HEMLIBRA . This is because:
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• The half-life of HEMLIBRA lasts for weeks and not hours (HEMLIBRA SmPC; Elocta SmPC)
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• It has convenient subcutaneous dosing with sustained protection (HEMLIBRA SmPC; Elocta
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SmPC)
• HEMLIBRA results is 68% fewer bleeds as compared to prior FVIII prophylaxis as observed
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over ≥24 weeks (HEMLIBRA SmPC; Mahlangu J et al. 2018)
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• It has proven safety without risk of FVIII inhibitors (HEMLIBRA SmPC)
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• It is trusted by more than 6100 patents worldwide (Callaghan M. 2019; HEMLIBRA SmPC)
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• About 98% patients preferred HEMLIBRA over FVIII prophylaxis after switching (Mahlangu J et
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al. 2018)

HEMLIBRA is widely available globally (Bloomberg. 2019). UAE was granted the approval for
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using HEMLIBRA in hemophilia A patients with inhibitors in June, 2018. The approval for its use
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in patients with non-inhibitors was received in October, 2018 (Roche. Data on file).

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