The FINANCIAL -- Bayer, together
with its cooperation partner, Janssen Research & Development, LLC,
announced today that the U.S. Food and Drug Administration has
granted Priority Review to the supplemental New Drug Applications
filed on May 2, 2012 for the oral anticoagulant Xarelto to treat patients with deep vein thrombosis (DVT) or
pulmonary embolism (PE) and to prevent recurrent DVT and PE.
The FDA grants Priority Review to medicines that offer major advances in care or provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), FDA will aim to complete its review within six months from the receipt of the sNDA submission, rather than the standard 10 month review cycle.
“The EINSTEIN studies have demonstrated convincingly that rivaroxaban can offer physicians a simple, single-drug solution for both the initial treatment of DVT or PE as well as the long-term prevention of recurrent VTE,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "The FDA’s Priority Review designation for rivaroxaban is an important step towards making this treatment available to even more patients in the U.S."
The submissions are supported by data from the global EINSTEIN clinical development program, which included almost 10,000 patients. The three Phase III studies evaluated the safety and efficacy of rivaroxaban in the treatment of DVT and PE and the prevention of recurrent VTE. As Bayer AG reported, results from these three studies have been published in the New England Journal of Medicine and demonstrated that rivaroxaban can offer the first oral single-drug solution for the initial treatment and long-term prevention of VTE.
Separately, Bayer and the cooperation partner Janssen Research & Development, LLC announced today that the supplemental New Drug Application (sNDA) filed with the FDA for the use of the oral anticoagulant Xarelto to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS) has been withdrawn. The decision is due to the complete response letter issued by the FDA regarding the separate sNDA for rivaroxaban to reduce the risk of secondary cardiovascular events in patients with ACS. Data from the ATLAS ACS 2-TIMI 51 study support both sNDAs.
"Together with our cooperation partner Janssen Research & Development, LLC, we are putting all our efforts behind the original submission for secondary prevention of ACS to address the questions raised by the FDA in their complete response letter as soon as possible,” said Dr. Kemal Malik.
Bayer and Janssen plan to resubmit the sNDA for rivaroxaban in stent thrombosis at the same time as the reply to the complete response letter in ACS.
Coronary stents are implanted in more than 1.5 million patients each year. Although stent thrombosis is rare, it is a catastrophic complication that can occur after a stent has been inserted into a patient’s coronary artery to keep the vessel open. If blood flow through the stent is restricted or blocked completely, the individual’s risk of forming an unwanted clot increases and can lead to a heart attack of even death.