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Alexion's Ondexxya approved for NHS Scotland to treat uncontrolled and life-threatening bleeds

Published on 09/09/20 at 12:37pm

The Scottish Medicines Consortium (SMC) has given its recommendation to Alexion’s Ondexxya (andexanet alfa) to routine use on NHS Scotland for the treatment of life-threatening or uncontrolled bleeding in adult patients treated with the direct Factor Xa (FXa) inhibitors apixaban or rivaroxaban, it has emerged.

According to data harvested from two Phase 3 studies and a Phase 3b safety study, Ondexxya was shown to “markedly reduce” anti-factor Xa activity of apixaban and rivaroxaban, while 82% of evaluable patients receiving the drug saw their bleeding stop 12 hours after treatment compared to baseline.

The drug has been approved on an interim basis that is contingent upon further assessment of its efficacy.

“As the number of patients on direct Fxa inhibitors continues to increase, so does the need to ensure we can protect patients who may experience life-threatening or uncontrolled bleeds,” commented Professor Henry Watson, Consultant Haematologist at University of Aberdeen. “Andexanet alfa will give clinicians an approved therapy option and clinical strategy for the reversal of major bleeding in patients being treated with rivaroxaban and apixaban. This is a positive step forward for the safety of patients being treated with these important and widely used drugs.”

Ondexxya was originally developed by Portola Pharmaceuticals, which was acquired by Alexion in July this year. The drug secured approval from the European Commission in April 2019 and from the FDA in May 2018.

Matt Fellows

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