FDA Areas Clinical Hold On Phase 3 Trial Of Novel Anticoagulant

A extremely promising novel anticoagulant method now appears to be in serious issues. Regado Biosciences announced these days that the FDA had positioned a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation technique. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant result.

REGULATE-PCI is a phase 3 trial evaluating Revolixys to bivalirudin (Angiomax, The Medicines Firm) in 13,000 patients undergoing PCI. The principal investigators of the trial are A. Michael Lincoff (Cleveland Clinic), Roxana Mehran (Mount Sinai), and John Alexander (Duke Clinical Investigation Institute).

The FDA action is not fully unexpected. On July 2 the company announced that patient enrollment in the trial had been paused when the Data Safety Monitoring Board (DSMB) initiated an unplanned assessment of trial data. The company explained the DSMB would “conduct a full evaluation of security and treatment advantage-danger ratio of all individuals enrolled to date (3234) with a emphasis on significant adverse occasions connected to allergic reactions.”

Regado mentioned the clinical hold was taken by the FDA “to formalize the involvement of the FDA in any selection to re-initiate enrollment and dosing in the trial in the future.” The organization CEO stated that “any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based mostly on the DSMB’s conclusions and would constantly be implemented in agreement with FDA.” The two the firm and the trial’s principal investigators stay blinded to the examine benefits.

FDA Areas Clinical Hold On Phase 3 Trial Of Novel Anticoagulant

Boehringer Ingelheim"s Oral Anticoagulant Gains New Indication

The new oral anticoagulants carry on to achieve extra indications from the FDA. Earlier these days Boehringer Ingelheim announced that the FDA had accredited Pradaxa (dabigatran) for the treatment of venous thromboembolism (VTE), which includes each deep venous thrombosis (DVT) and pulmonary embolism (PE).

Last month Bristol-Myers Squibb’s and Pfizer’s Eliquis (apixaban) gained an indication for VTE prophylaxis following hip or knee substitute surgical procedure. Johnson &amp Johnson’s Xareleto (rivaroxaban) had presently received this indication. Hence, all 3 of the new oral anticoagulants have now received FDA approval for the main indications of stroke prevention in patients with nonvalvular atrial fibrillation (SPAF), DVT prophylaxis following hip or knee substitute surgical procedure, and treatment method of folks who have or have had VTE.

1 significant variation in the VTE treatment labels is that both Eliquis and Xarelto have been studied using a single-drug approach. These medication are authorized for acute use in the hospital and for continued use afterwards. By contrast, Pradaxa was studied in individuals after they had received parenteral anticoagulants and is indicated for use following therapy with a parenteral anticoagulant for five to 10 days. It can also be utilised in individuals who have been previously treated for VTE.

“Venous thromboembolism is the third most typical cardiovascular disease soon after myocardial infarction and stroke. About one-third of patients with a DVT or PE will suffer a recurrence inside of 10 years,” stated Samuel Z. Goldhaber, in a Boehringer Ingelheim press release. “Dabigatran has established efficacy and security for stroke danger reduction in individuals with non-valvular atrial fibrillation. This new FDA approval expands dabigatran’s indications to consist of therapy and the reduction of the chance of recurrence of DVT and PE.”

The new indication is based mostly on outcomes from four global Phase III scientific studies evaluating the efficacy and safety of Pradaxa in the therapy of DVT and PE: RE-COVER, RE-COVER II, RE-MEDYSM, and RE-SONATE.

Boehringer Ingelheim"s Oral Anticoagulant Gains New Indication

FDA Grants New Indication For Pfizer/Bristol Anticoagulant

The FDA has authorized a new indication for apixaban (Eliquis), the anticoagulant drug produced by Bristol-Myers Squibb Bristol-Myers Squibb and Pfizer Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in individuals who have undergone hip or knee replacement surgery. DVT can lead to the lifestyle-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously approved indication of stroke prevention in sufferers who have nonvalvular atrial fibrillation.

In accordance to the organizations, approximately 719,000 total knee substitute surgeries and 332,000 hip replacement surgeries are performed each and every year in the US. The use of anticoagulants are suggested in these patients simply because they are at elevated danger for developing DVT and PE.

The new indication is based mostly on results of the ADVANCE clinical trial program in which apixaban was compared to enoxaparin in far more than 11,000 individuals.

Between the new oral anticoagulants only rivaroxaban (Xarelto, Johnson &amp Johnson Johnson &amp Johnson) had been authorized previously for DVT prophylaxis in orthopedic patients.

FDA Grants New Indication For Pfizer/Bristol Anticoagulant

Issues Persist In spite of Gains In Oral Anticoagulant Use

Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk of stroke. Many elderly patients are not receiving oral anticoagulants– either traditional warfarin or one of the newer anticoagulants (Pradaxa, Boehringer Ingelheim, Xarelto, Johnson & Johnson; and Eliquis (Pfizer and BristolMyers Squibb)– and overall too many patients are still taking aspirin, despite the fact that it is not recommended for this group of patients.

In a paper published in the American Journal of Medicine, Gregory YH Lip and colleagues analyzed data from more than 3,100 patients surveyed in the Euro Observational Research Programme on Atrial Fibrillation from February 2012 to March 2013. They found that the use of oral anticoagulants has improved over the past decade. A large majority– 72%– received warfarin while only 8% received one of the newer oral antigcoaulants.

“Novel oral anticoagulant uptake is still a bit low, probably because of differences in regulatory approval, costs and access to drugs in different countries,” said Dr. Lip, in an ESC press release. “But the main point is that overall oral anticoagulant uptake as a whole has improved in the last 10 years.”

The authors expressed concern about the persistent high use of aspirin among patients in the survey. “The perception that aspirin is a safe and effective drug for preventing strokes in AF needs to be dispelled,” said Lip. “If anything, you could say that giving aspirin to patients with AF is harmful because it is minimally or not effective at stroke prevention, yet the risk of major bleeding or intracranial haemorrhage is not significantly different to well-managed oral anticoagulation.” Aspirin is commonly prescribed as an antiplatelet agent in patients with coronary artery disease, especially following an acute coronary syndrome. In the survey AF patients with coronary disease were eight time more likely to be taking aspirin.

A finding of particular concern was the underuse of oral anticoagulants in elderly patients. Said Lip: “Elderly patients are at the highest risk for stroke and yet they are given aspirin which is not recommended and potentially harmful. There is a perception that elderly patients do not do well on anticoagulation.” But, he said, warfarin is actually “far superior” to aspirin in these patients for the prevention of stroke.

Issues Persist In spite of Gains In Oral Anticoagulant Use