Posts Tagged ‘reversal’
Stephan Moll, MD writes… The FDA did NOT approve Andexanet (brand names: AndexXa™ in the US, IndexXa™ in Europe) in a decision on August 18th, 2016. Andexanet is the drug in clinical trials as an antidote to reverse the blood thinning effect of Eliquis®, Savaysa®, Xarelto® and Lovenox® (= enoxaparin). The FDA is said to have requested more information from the company (Portola) making Andexanet, specifically (a) additional information related to manufacturing of the drug, and (b) more data to support inclusion of Savaysa and Lovenox (enoxaparin) in the label. The FDA also wants to finalize its review of the company’s proposals for post-marketing data collection on the performance of the drug.
It needs to be seen when the company (Portola) submits the requested additional information and when a new decision from the FDA is then to be expected. My guess is that this will be sometime in 2017.
- Portola announcement from Aug 18, 2016: http://bit.ly/2c1wKaK
- Connolly SJ et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. NEJM 2016;Aug 30 [e-pub]
Disclosure: I have consulted for Portola, Janssen, and Boehringer-Ingelheim.
Last updated: Aug 31st, 2016
Stephan Moll, MD writes (on Nov 7th, 2014)… A publication this week in the New England Journal of Medicine reports on a new reversal agent (PER977 = Aripazine = ciraparantag) that may be effective against a number of different new oral anticoagulants [ref 1]. Read the rest of this entry »
Stephan Moll, MD writes… Major bleeds on blood thinners (such as Coumadin, Jantoven, Eliquis, Pradaxa, Xarelto) and anti-platelet drugs (like aspirin, Plavix, Brilinta, Effient, etc.) occur every so often. Quick action in Emergency Departments is needed in case of such bleeds. Our medical center (University of North Carolina Hospitals, Chapel Hill) has put together an “Emergent Anticoagulation Reversal Guideline” for our local use as a practical, clinical how-to document (PDF here). Since not every medical institution has pharmacists and MDs with clotting expertise available to develop its own guideline, we are making this document available through Clot Connect and invite colleagues and hospitals to take the document if they like, modify it, and apply it to their institution.
Disclosures: I have been a consultant for CSL Behring and Janssen.
Last updated: June 9th, 2014
Stephan Moll, MD writes…
Interesting publication this week in Circulation: “Management and outcomes of major bleeding during treatment with dabigatran or warfarin” (Majeed A et al; published online Sept 30,2013; full publication is here). The management and prognosis of major bleeding in patients treated with dabigatran or warfarin was compared, pooling data of the major bleeds that occurred in 5 phase III dabigatran trials. 1,121 major bleeds occurred in 27,419 patients treated with warfarin or dabigatran. Read the rest of this entry »
Major and life-threatening bleeding is expected to occur in some patients treated with Pradaxa® (=Dabigatran). The question will then urgently arise how to best treat such catastrophic bleeding. As there have been no data published on this topic in the peer-reviewed medical literature, we don’t know how to best manage a patient with major and life-threatening bleeding Read the rest of this entry »