U.S. FDA Grants Priority Review for XARELTO® (rivaroxaban) Supplemental NDAs for the Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and the Long-Term Prevention of Recurrent DVT and PE

Published July 9, 2012

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2, 2012 for XARELTO® (rivaroxaban), an oral anticoagulant, seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.

DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and is carried to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery.

"We are delighted to have received a priority review designation for XARELTO® for the treatment of PE and DVT, and also to prevent the recurrence of these conditions. Each year an estimated 900,000 Americans experience a DVT or PE, and one third of those events are fatal. If approved for these indications, XARELTO® has the potential to address critical unmet needs in treating patients with these serious medical conditions," said Paul Burton, MD, PhD, Vice President, Cardiovascular Franchise Medical Leader at Janssen R&D.

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 submissions are supported by data from the global EINSTEIN program, which includes two Phase 3 studies evaluating the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent events in these patients. A third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE. In total, these Phase 3 studies included more than 9,400 patients.

Separately, Janssen R&D announced it is withdrawing the sNDA for the use of XARELTO® to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS).  The company is withdrawing this sNDA because it is contingent on a separate sNDA, for XARELTO® to reduce of the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on June 21, 2012.  Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

"We remain confident in the overall study results from the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for this separate sNDA," said Dr. Burton. "Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible.  We plan to resubmit the sNDA for stent thrombosis at the same time."

Stent thrombosis is an uncommon, but potentially catastrophic complication that may occur after a stent has been inserted into a patient's coronary artery and can result in a heart attack or even death. Coronary stents are implanted in more than 1.5 million patients each year.

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U.S. FDA Grants Priority Review for XARELTO® (rivaroxaban) Supplemental NDAs for the Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and the Long-Term Prevention of Recurrent DVT and PE

Published July 9, 2012

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2, 2012 for XARELTO® (rivaroxaban), an oral anticoagulant, seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.

DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and is carried to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery.

"We are delighted to have received a priority review designation for XARELTO® for the treatment of PE and DVT, and also to prevent the recurrence of these conditions. Each year an estimated 900,000 Americans experience a DVT or PE, and one third of those events are fatal. If approved for these indications, XARELTO® has the potential to address critical unmet needs in treating patients with these serious medical conditions," said Paul Burton, MD, PhD, Vice President, Cardiovascular Franchise Medical Leader at Janssen R&D.

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 submissions are supported by data from the global EINSTEIN program, which includes two Phase 3 studies evaluating the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent events in these patients. A third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE. In total, these Phase 3 studies included more than 9,400 patients.

Separately, Janssen R&D announced it is withdrawing the sNDA for the use of XARELTO® to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS).  The company is withdrawing this sNDA because it is contingent on a separate sNDA, for XARELTO® to reduce of the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on June 21, 2012.  Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

"We remain confident in the overall study results from the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for this separate sNDA," said Dr. Burton. "Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible.  We plan to resubmit the sNDA for stent thrombosis at the same time."

Stent thrombosis is an uncommon, but potentially catastrophic complication that may occur after a stent has been inserted into a patient's coronary artery and can result in a heart attack or even death. Coronary stents are implanted in more than 1.5 million patients each year.

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