Education Blog for Healthcare Professionals

Posts Tagged ‘FDA’

NO FDA Approval Yet for Andexanet

| Anticoagulants, Bleeding, Therapy, Uncategorized | Comments Off on NO FDA Approval Yet for Andexanet

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 antidote in clinical development to reverse the anticoagulant effect of Eliquis® (rivaroxaban), Savaysa® (edoxaban), Xarelto® (rivaroxaban) 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®  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 to the FDA 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

Pradaxa (Dabigatran) FDA-Approved for DVT and PE

| Eliquis, Pradaxa (dabigatran), Therapy, Uncategorized, Xarelto (Rivaroxaban) | Comments Off on Pradaxa (Dabigatran) FDA-Approved for DVT and PE

Stephan Moll, MD writes…  Today the FDA approved Pradaxa (dabigatran) for the treatment of venous thromboembolism, based on the phase 3 RECOVER and RECOVER II trials.  The dose is 150 mg twice daily for patients with a GFR > 30 ml/min.  Due to the design of the RECOVER and RECOVER II trials, the drug is approved to be used in the patient with acute DVT or PE only AFTER 5-10 days of a parenteral anticoagulant have been given –  not immediately from day zero onwards.   The full package insert is here.  The press release from Boehringer-Ingelheim is here.   The FDA approval status of the four big new oral anticoagulants for the various indications is summarized  in this table.

 

Disclosures:  I have been a consultant for Boehringer-Ingelheim,  Daiichi, and Janssen.

Last updated:  April 7th, 2014

Moving Fast: 4th Big New Oral Anticoagulant (Edoxaban, Savaysa) Applies For FDA Approval

| Uncategorized | Comments Off on Moving Fast: 4th Big New Oral Anticoagulant (Edoxaban, Savaysa) Applies For FDA Approval

Stephan Moll, MD writes… 2014 promises to be quite a year regarding the new oral anticoagulants. On Jan 8th, 2013 the company Daiichi applied for FDA approval for their drug edoxaban (Savaysa®) for 2 indications: (a)  DVT and PE (venous thromboembolism; VTE) treatment, and (b) non-valvular atrial fibrillation and the prevention of systemic arterial thromboembolism. This application is based on the 2 large phase 3 edoxaban trials, one in VTE, one in A. fib, both published in the New England Journal of Medicine in 2013 [ref 1,2].

Here is a summary of the FDA approval status and application status of the 4 big new oral anticoagulants. Also On Jan 8th, 2014, the brand name of edoxaban was announced: Savaysa (Daiichi press release here).

 

References

  1. The Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thrmomboembolism. N Engl J Med 2013;369:1406-1415 (Oct 10, 2013).
  2. Giugliano RP et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369(22):2093-104(Nov 28, 2013).

 

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

Last updated: March 14th, 2013

 

FDA to Review Eliquis (Apixaban) for DVT and PE Treatment

| Anticoagulants, Eliquis, Pradaxa (dabigatran), Uncategorized, Xarelto (Rivaroxaban) | Comments Off on FDA to Review Eliquis (Apixaban) for DVT and PE Treatment

Stephan Moll, MD writes… On Dec 19th the FDA accepted the application by Bristol-Myers Squibb (BMS) and Pfizer for review of Eliquis (apixaban) for the treatment of DVT and PE. The press release of BMS is here.  The goal date for a decision by the FDA is August 25, 2014. Read the rest of this entry »

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

Xarelto (Rivaroxaban) Approved For A. Fib

| Uncategorized, Xarelto (Rivaroxaban) | Comments Off on Xarelto (Rivaroxaban) Approved For A. Fib

Today the FDA approved Xarelto (Rivaroxaban) for atrial fibrillation.  The approved dose is 20 mg once daily. The link to the FDA press release is here.  The Xarelto prescribing information can be found here.

Xarelto for Venous Thromboembolism

Xarelto is NOT approved at this point for treatment of DVT or PE Read the rest of this entry »

Yasmin, Yaz and Other Drospirenone Contraceptives: Risk for VTE

| Uncategorized, Women and blood clots | Comments Off on Yasmin, Yaz and Other Drospirenone Contraceptives: Risk for VTE

It has long been known that estrogen-containing birth control preparations (pill, patch, ring) increase the risk for DVT and PE (venous thromboembolism = VTE).  This risk is partially due to the estrogen.  However, part of the risk is also due to the type of progestin in these preparations. Read the rest of this entry »