Date: 2011-12-19
Type of information: Granting of a Market Authorisation in the US
Product name: Eliquis®
Compound: apixaban
Therapeutic area: Cardiovascular diseases
Action mechanism: this anticoagulant agent is a direct factor Xa inhibitor.
Company: BMS (USA - NY) Pfizer (USA - NY)
Disease: prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery
Latest news: * On March 14, 2014, BMS and Pfizer have announced that the FDA approved a Supplemental New Drug Application (sNDA) for Eliquis® (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. The full Prescribing Information for Eliquis includes Boxed Warnings for the increased risk of stroke in patients with nonvalvular atrial fibrillation who discontinue Eliquis® without adequate continuous anticoagulation; and for the increased risk of epidural or spinal hematoma, which may cause long-term or permanent paralysis, in patients using Eliquis and undergoing spinal epidural anesthesia or spinal puncture. Please see complete Boxed Warnings and additional Important Safety Information in this press release.
This sNDA approval for Eliquis is supported by three clinical trials (the ADVANCE clinical trial program). The ADVANCE trials randomized more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin, to assess the safety and efficacy of Eliquis. In December 2013, the FDA accepted for review another sNDA for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-03-14
UE authorization: 2011-05-18
Favourable opinion UE: 2011-03-17
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
