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 & 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.