Patient Education Blog

Posts Tagged ‘FDA’

NO FDA Approval Yet for Antidote for Xarelto, Eliquis and Savaysa

| Bleeding, Blood thinners (anticoagulants), Therapy | Comments Off on NO FDA Approval Yet for Antidote for Xarelto, Eliquis and Savaysa

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.

References

  1. Portola announcement from Aug 18, 2016: http://bit.ly/2c1wKaK
  2. Connolly SJ et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. NEJM 2016;Aug 30 [e-pub]
     (http://dx.doi.org/10.1056/NEJMoa1607887)

 

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

Last updated: Aug 31st, 2016

Eliquis (Apixaban) FDA-Approved for DVT and PE Treatment

| Blood thinners (anticoagulants), Eliquis - Apixaban, Pradaxa - dabigatran, warfarin / coumadin, Xarelto - Rivaroxaban | Comments Off on Eliquis (Apixaban) FDA-Approved for DVT and PE Treatment

Stephan Moll, MD writes…  Apixaban (Eliquis®) was approved by the FDA this week (Aug 21, 2014) for the treatment of DVT and PE.  The approval covers (a) acute DVT/PE management and (b) the longer-term prevention of recurrent DVT/PE. Read the rest of this entry »

The New Oral Anticoagulants: Update on FDA Applications

| Blood thinners (anticoagulants), Eliquis - Apixaban, Pradaxa - dabigatran, Savaysa - Edoxaban, Xarelto - Rivaroxaban | Comments Off on The New Oral Anticoagulants: 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, as far as I know, for any indication.

 

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

Last updated: Aug 28th, 2013

New Blood Thinner (Eliquis = Apixaban) FDA Approved

| Blood thinners (anticoagulants), Eliquis - Apixaban, Therapy | Comments Off on New Blood Thinner (Eliquis = Apixaban) FDA Approved

Stephan Moll, MD writes…  Another new oral blood thinner (Eliquis = apixaban) was approved by the FDA on Dec 28th, 2012 – to be used by patients with irregular heart beat (atrial fibrillation) to prevent stroke.  The drug is NOT yet FDA-approved for treatment of patients with DVT or PE.  Clinical trials evaluating Eliquis for this indication are still ongoing. Read the rest of this entry »

Yasmin, Yaz, Angeliq and Risk for Blood Clots

| Women and blood clots | Comments Off on Yasmin, Yaz, Angeliq and Risk for Blood Clots

Birth control pills, patches and rings typically contain an estrogen and a progestin component.  It has long been known that estrogen-containing birth control preparations (pill, patch, ring) increase the risk for blood clots (DVT, PE).  This risk is partially due to the estrogen.  However, part of the risk for clots is also due to the type of progestin in these preparations. Read the rest of this entry »