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Archive for the ‘Eliquis’ Category

New Oral Anticoagulants for DVT and PE: Update on FDA Applications

| Eliquis, Pradaxa (dabigatran), Uncategorized, Xarelto (Rivaroxaban) | Comments Off on New Oral Anticoagulants for DVT and PE: Update on FDA Applications

Stephan Moll, MD writes…

 

1.  Pradaxa (Dabigatran)

  • Today, August 28th, 2013, it was announced that the FDA is reviewing the application by Boehringer-Ingelheim to get Pradaxa (dabigatran) approved for use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) – details here.
  • At present, in the US, Pradaxa is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.

2.  Eliquis (Apixaban)

  • On July 11th , 2013 the company making Eliquis applied for FDA approval of their drug for DVT and PE prevention after hip and knee replacement surgery – details here.
  • The company has not yet filed for approval of the drug for DVT and PE treatment.
  • At present, in the US, Eliquis is only FDA-approved for prevention of stroke and other arterial clots in patients with irregular heart beat.

3.  Xarelto (Rivaroxaban)

  • Xarelto is, at present the only one of the new oral anticoagulants that is FDA-approved for the treatment of DVT and PE.  It is also approved for (a) DVT and PE prevention after hip and knee replacement surgery, and (b) for prevention of stroke and other arterial clots in patients with irregular heart beat.

4.  Edoxaban

  • This new oral anticoagulant by the Japanese company Daiichi is not FDA-approved at this time and no FDA review of data is pending.

 

Disclosure:  I have consulted for Janssen, Daiichi, Boehringer Ingelheim.

Last updated: Sept 1st, 2013

International Coagulation Meeting (ISTH 2013): Highlights

| Anticoagulants, Deep Vein Thrombosis (DVT), Eliquis, Inherited, Pradaxa (dabigatran), Pulmonary Embolism, Therapy, Thrombophilias, Uncategorized, Xarelto (Rivaroxaban) | Comments Off on International Coagulation Meeting (ISTH 2013): Highlights

Stephan Moll, MD writes…  A major international coagulation conference, the bi-annual meeting of the International Society for Thrombosis and Haemostasis (ISTH; www.isth.org), took place in Amsterdam, Holland, from June 29th to July 4th, 2013.  The clinically relevant highlights about thrombosis and anticoagulation are summarized below. Read the rest of this entry »

New Publication: Eliquis (Apixaban) is Effective and Safe in DVT and PE

| Deep Vein Thrombosis (DVT), Eliquis, Pulmonary Embolism, Uncategorized, Venous Clots | Comments Off on New Publication: Eliquis (Apixaban) is Effective and Safe in DVT and PE

Stephan Moll, MD writes…  

An important study (AMPLIFY trial) was published today in the New England Journal of Medicine [ref 1]: In a large study of 5395 patients with acute DVT or PE, Eliquis (apixaban) was as effective as warfarin and caused less major bleeding. Read the rest of this entry »

Antidote for New Oral Xa-Inhibitors (Eliquis, Xarelto): Phase 2 Study

| Eliquis, Uncategorized | Comments Off on Antidote for New Oral Xa-Inhibitors (Eliquis, Xarelto): Phase 2 Study

Stephan Moll, MD writes….

The pharmaceutical company Portola reported today (May 8th, 2013) without many details on the  findings of their phase 2 human volunteer study of their anti-Xa anticoagulant antidote PRT4445 — ClinicalTrials.gov Identifier: NCT01758432 (study description here). In this study, healthy volunteers who had taken Eliquis (Apixaban) received the antidote.  The study showed a “rapid and sustained and dose-related reversal of the anticoagulant activity of Eliquis” (thrombin generation and anti-factor Xa activity) and “no serious adverse events”.

PRT4445 is a recombinant  molecule, structurally very similar to native factor Xa, but with some modifications that make it inactive as a clotting factor.  It acts as a decoy for factor Xa inhibitor drugs, binding them. Once they are bound they are unable to bind to and inhibit native factor Xa. Thus, the native factor Xa becomes available to participate in the coagulation process and normal hemostasis is restored.

The full Portola report is here.  The data of the study still need to be presented at a medical meeting and published.  At this point all that can be concluded is that the drug is reported to have an ex vivo effect on coagulation tests.  Whether it has any clinical efficacy in major bleeding associated with Eliquis or any of the other new oral anti-Xa anticoagulants (Xarelto=rivaroxaban; Edoxaban) has yet to be investigated.

 

Disclosure:  I have consulted for Janssen, Boehringer-Ingelheim, and Daiichi.

Last updated:  May 8th, 2013

 

 

Top 10 Publications on Thrombosis and Anticoagulation from 2012

| Arterial Clots, Aspirin, Plavix, Aggrenox, Tiklid, Persantine, Deep Vein Thrombosis (DVT), Eliquis, Other topics, Pradaxa (dabigatran), Pulmonary Embolism, Uncategorized, Venous Clots, Warfarin (Coumadin), Xarelto (Rivaroxaban) | Comments Off on Top 10 Publications on Thrombosis and Anticoagulation from 2012

Stephan Moll writes…

2012 has been a year with significant progress in the field of venous thromboembolism and anticoagulation.  The three most noteworthy, clinically relevant developments were probably (a) the publication of the new ACCP (American College of Chest Physician) guidelines on antithrombotic therapy in February 2012; (b)  The FDA-approval of rivaroxaban (Xarelto) in November 2012 for the acute treatment of venous thromboembolism (VTE) and long-term secondary prevention; and (c) The FDA-approval of apixaban (Eliquis) in December 2012 for atrial fibrillation and the prevention of arterial thromboembolism.  Here I have listed and summarized the 10 top publications of 2012  in the field of venous thromboembolism and anticoaguation as I see them – the ones clinically most relevant. 

 

Disclosure: I have consulted for Janssen, Boehringer-Ingelheim and Daiichi.

Last updated: Feb 7th, 2013

 

Apixaban (Eliquis) – Hospital Guideline

| Anticoagulants, Eliquis, Guideline, Therapy, Uncategorized | Comments Off on Apixaban (Eliquis) – Hospital Guideline

Stephan Moll, MD writes…

Apixaban (Eliquis®) is FDA-approved for the prevention of  stroke and systemic arterial thromboembolism in patients with atrial fibrillation (Clot Connect discussion of the approval on  Dec 28th, 2012 is here).  Here is the management guideline for apixaban Read the rest of this entry »

Apixaban (Eliquis) News – Plus Update On The Big Four New Oral Anticoagulants

| Anticoagulants, Eliquis, Therapy, Uncategorized, Xarelto (Rivaroxaban) | 2 Comments »

There is a lot of appropriate interest and excitement today about one of the four new oral anticoagulants in development – Apixaban (Eliquis). Data from the large ARISTOTLE trial were published today in the NEJM, showing that in patients with atrial fibrillation Apixaban was more effective in preventing stroke and systemic thromboembolism, caused less major bleeding, and resulted in lower mortality than warfarin in patients with non valvular atrial fibrillation [ref 1].  This is good news. Read the rest of this entry »