Posts Tagged ‘apixaban’

December 12th, 2012


John Ryan reviews the latest data and suggests that DVT/PE be managed as a chronic condition. Are you using apixaban in these patients, and how long are you treating them for?

December 8th, 2012

Prolonged Anticoagulation with Apixaban Beneficial in Venous Thromboembolism

A new study suggests that extending anticoagulant therapy for an additional year may be beneficial after patients with venous thromboembolism complete their initial course of therapy. The results of AMPLIFY-EXT (Apixaban after the Initial Management of Pulmonary Embolism and Deep Vein Thrombosis with First-Line Therapy-Extended Treatment) were presented at the annual meeting of the American Society […]

September 27th, 2012

FDA Sets New Decision Date for Eliquis (Apixaban)

The FDA  will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb. The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly praised when […]

September 21st, 2012

Apixaban (Eliquis) For Atrial Fibrillation Gets Positive European Recommendation

The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval for apixaban (Eliquis, Pfizer and BristolMyers Squibb) for atrial fibrillation. The drug is already approved in Europe for the prevention of venous thromboembolic events following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here is the CHMP-proposed indication for the […]

June 25th, 2012

FDA Once Again Delays Approval of Apixaban (Eliquis)

The FDA has once again delayed approval of apixaban (Eliquis), the much-anticipated oral anticoagulant. Bristol-Myers Squibb and Pfizer announced today that it had received a a Complete Response Letter (CRL) to the New Drug Application (NDA) for the drug for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The two companies reported that […]

April 25th, 2012

When You’re Hot, You’re Hot: Salim Yusuf Second Most Influential Scientist in 2011

McMaster University’s Salim Yusuf has tied for second place in the annual ranking of the “hottest” scientific researchers, according to Thomson Reuter’s Science Watch. Yusuf was a co-author of 13 of the most cited papers in 2011. Only one other researcher, genomic pioneer Eric Lander of the Broad Institute of MIT and Harvard, had more highly-cited papers than Yusuf. Two of […]

March 1st, 2012

Decision on Apixaban (Eliquis) Pushed Back By 3 Months

Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers Squibb announced on Wednesday evening that the FDA had extended by 3 months the action date for the new drug application (NDA) for the highly anticipated oral anticoagulant apixaban (Eliquis). The application is for their important indication of stroke prevention in atrial fibrillation. The […]

November 13th, 2011

ADOPT Fails to Support Extended Oral Apixaban in High-Risk Post-Discharge Patients

Although medically ill patients remain at risk for VTE after hospital discharge, a strategy of extended oral anticoagulation with apixaban did not prove to be successful in the ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) trial, which was presented by Samuel Z. Goldhaber at the American Heart Association and published simultaneously in the New England […]

September 6th, 2011

FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)

FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers is […]

August 30th, 2011

Is Warfarin Still the First Choice in Atrial Fibrillation?

There’s an old maxim in medicine that one shouldn’t be the first to prescribe a new drug, nor the last. A fascinating debate between Michael Ezekowitz from the U.S. and Felicita Andreotti from Italy highlighted the differences between warfarin and the newer oral anticoagulants (NOACs) apixaban, rivaroxaban, and dabigatran. Even Dr. Ezekowitz, the warfarin protagonist for purposes […]