Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3 Randomized, Double-blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Rivaroxaban Anticoagulation With Intravenously Administered Andexanet Alpha

Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled Study in Older Subjects to Assess Safety and the Reversal of Rivaroxaban Anticoagulation With Intravenously Administered Andexanet Alpha

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Andexanet alfa (Primary) ; Rivaroxaban
  • Indications Haemorrhage
  • Focus Registrational; Therapeutic Use
  • Acronyms ANNEXA-R
  • Sponsors Portola Pharmaceuticals
  • Most Recent Events

    • 26 Apr 2019 According to a Portola Pharmaceuticals media release, based on results of ANNEXA-R, ANNEXA-A and ANNEXA-4 (n=352), studies, the European Commission (EC) has granted conditional Marketing Authorization of Ondexxya (andexanet alfa) for the treatment of the adult patients with the Factor Xa inhibitor apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
    • 01 Mar 2019 According to a Portola Pharmaceuticals media release, the CHMP has recommended that the European Commission (EC) grant Ondexxya conditional approval for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban or rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding. The EC is expected to issue a decision in early May 2019.
    • 01 Mar 2019 According to a Portola Pharmaceuticals media release, based on results of this study, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion on the marketing authorization application (MAA) for Ondexxya (andexanet alfa).
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with a username/password associated to your organization’s account.
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Federated access using single sign-on credentials.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top