Eliquis Nipping At The Heels of NOAC Market Leader Xarelto

–But the overall market for the new oral anticoagulants continues to expand. The new oral anticoagulant (NOAC) market is growing larger and is becoming increasingly competitive. The latest market data shows that apixaban (Eliquis, Pfizer and BristolMyers Squibb) is challenging the established leader in the field, rivaroxaban (Xarelto, Johnson & Johnson). According to recent data…

Click here to continue reading…

FDA Grants New Indication For Apixaban

The FDA today approved an expanded indication for  the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. … Click here to…

Click here to continue reading…

Boehringer Ingelheim’s Pradaxa Gains New Indication

The new oral anticoagulants continue to gain additional indications from the FDA. Earlier today Boehringer Ingelheim announced that the FDA had approved Pradaxa (dabigatran) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE). …  Click here to read the full post on Forbes.    …

Click here to continue reading…

Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents

After the presentation and publication of the pivotal ARISTOTLE trial,  the novel anticoagulant apixaban (Eliquis, Pfizer and BristolMyers Squibb) was widely expected to be  a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Ultimately approval of the drug was delayed for 9…

Click here to continue reading…

New Studies Examine Prolonged Anticoagulation For VTE Recurrence

Three studies published in the New England Journal of Medicine provide important new information about the risks and benefits of extended prophylaxis using two of the new oral anticoagulants in patients who have had venous thromboembolism (VTE). … In an accompanying editorial, Jean Connors writes that “deciding how to balance the risks and benefits of extended anticoagulation is…

Click here to continue reading…

Two Experts Help Sort Out The New Generation Of Anticoagulants

Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts. Christian Thomas Ruff: I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients…

Click here to continue reading…

Prolonged Anticoagulation With Apixaban Found 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…

Click here to continue reading…

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 BristolMyers Squibb. The new drug application (NDA) for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was…

Click here to continue reading…

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 (AF). The drug is already approved in Europe for the prevention of venous thromboembolic events (VTE) following hip or knee replacement surgery. The drug has not yet been approved in the United States. Here…

Click here to continue reading…

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…

Click here to continue reading…

Decision on Apixaban (Eliquis) Pushed Back By Three Months

Update, March 1, 5 PM: Ramsay Baghadi of the RPM Report says that the Cardiorenal committee will take up the apixaban NDA on Mary 22 and the rivaroxaban supplemental NDA for the ACS indication on May 23, but this information has not been confirmed. Confirming earlier speculation by a Wall Street analyst, Pfizer and Bristol-Myers…

Click here to continue reading…