2019年2月28日，人用药品委员会（CHMP）采纳了积极的意见，建议对药品Ondexxya给予有条件的上市许可*，用于在用阿哌沙班或利伐沙班逆转抗凝时使用由于危及生命或无法控制的出血。该药品的申请人是Portola Netherlands B.V.

Ondexxya将以200毫克粉末形式提供，用于输液。活性物质是andexanet alfa，属于药物治疗组解毒剂（ATC代码：V03AB38）。 Andexanet alfa是人因子Xa蛋白的重组形式，其与利伐沙班或阿哌沙班（直接因子Xa抑制剂）以高亲和力结合，使得它们不能发挥其抗凝血作用。

Ondexxya的好处是能够逆转利伐沙班和阿哌沙班的抗凝血活性。它可以酌情与标准支持措施结合使用。临床疗效基于健康志愿者中抗因子Xa活性的逆转以及危及生命的出血患者的中期结果。预期进一步确认抗因子Xa活性与出血患者的止血功效和推荐的剂量学之间的相关性。在用Ondexxya治疗后已报道血栓形成事件，并且不能排除促血栓形成作用。

完整的迹象是：

“对于因直接因子Xa（FXa）抑制剂（阿哌沙班或利伐沙班）治疗的成年患者，由于危及生命或无法控制的出血，需要逆转抗凝治疗。”

有关使用本产品的详细建议将在产品特性摘要（SmPC）中进行描述，该摘要将在欧洲公共评估报告（EPAR）中公布，并在获得上市许可后以所有欧盟官方语言提供。由欧洲委员会。

28 February 2019

EMA/CHMP/40684/2019

Committee for Medicinal Products for Human Use (CHMP)

Summary of opinion1 (initial authorisation)

Ondexxya

andexanet alfa

On 28 of February 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation2 for the medicinal product Ondexxya, intended for use when reversal of anticoagulation with apixaban or rivaroxaban is needed due to life-threatening or uncontrolled bleeding. The applicant for this medicinal product is Portola Netherlands B.V.

Ondexxya will be available as a 200 mg powder for solution for infusion. The active substance is andexanet alfa, belonging to the pharmacotherapeutic group antidotes (ATC code: V03AB38). Andexanet alfa is a recombinant form of human factor Xa protein which binds to rivaroxaban or apixaban (direct factor Xa inhibitor) with high affinity, rendering them unable to exert their anticoagulant effects.

The benefits with Ondexxya are its ability to reverse the anticoagulant activity of rivaroxaban and apixaban. It can be used in conjunction with standard supportive measures as appropriate. Clinical efficacy is based upon reversal of anti-factor Xa activity in healthy volunteers and interim results in patients with life threatening bleeding. Further confirmation of the correlation between anti-factor Xa activity and haemostatic efficacy in bleeding patients and of the recommended posology is expected. Thrombotic events have been reported following treatment with Ondexxya and a pro-thrombotic effect cannot be ruled out.

The full indication is:

“For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion

2 A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to

public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

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