ANDEXANET ALFA (ONDEXXYA®) NICE FAD Media Statement

Alexion welcomes NICE’s (National Institute for Care and Health Excellence) decision to recommend andexanet alfa (ONDEXXYA^®▼) for reversing anticoagulation of the direct factor Xa (FXa) inhibitors apixaban or rivaroxaban in adult patients who experience a life-threatening or uncontrolled bleed in the gastrointestinal (GI) tract. We are disappointed however that NICE is recommending andexanet alfa in research only in patients who experience a life-threatening or uncontrolled intracranial haemorrhage (ICH) bleed when taking apixaban or rivaroxaban. Despite treatment with usual care in an intensive care setting, more than 40 percent of patients with ICH bleeds die within 30 days.¹ By not recommending andexanet alfa for ICH bleeds, we believe this may result in inequity of care for patients requiring reversal of serious bleeding associated with the use of apixaban and rivaroxaban.

Until now, there has been no licensed therapy to reverse FXa-associated major bleeds when treated with apixaban or rivaroxaban, which are increasingly used for the prevention and treatment of thrombotic events, such as deep vein thrombosis and pulmonary embolism, or if a patient is at high risk of a stroke due to an irregular heart rate (atrial fibrillation). While these direct FXa inhibitors stop the blood from clotting normally in order to prevent unwanted clots from forming, in doing so, they can also increase the risk of major bleeding which can be life-threatening.^2,3 Studies have shown that andexanet alfa can reverse the anticoagulant effect of apixaban or rivaroxaban within two minutes of administration, and that 82% of patients responded well to the treatment.⁴

Alexion is collecting additional data for the use of andexanet alfa in ICH bleeds and is committed to continuing to work closely with NICE, NHS England and all other stakeholders to find a sustainable path forward to secure future funded access to andexanet alfa for those patients in England who experience an ICH bleed and could benefit from this first-in-class therapy.

Alexion Media Contact

Megan Goulart, 857-338-8634

Executive Director, Corporate Communications

References

1. van Asche C, et al. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. Available at: https://pubmed.ncbi.nlm.nih.gov/20056489/
2. Held C, Hylek EM, Alexander JH, et al. Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial. Eur Heart J 2015;36:1264-1272.
3. Piccini JP et al. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. European Heart Journal 2014;35:1873–1880.
4. Connolly S.J et al. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2019. 380. 10.1056/NEJMoa1814051. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1814051.