FDA Committee Finds Favorable Profile For Rivaroxaban For DVT And Pulmonary Embolism After Hip/Knee Surgery

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Mar 2009 - 1:00 PDT

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Ortho-McNeil announced that the U.S. Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee has determined that rivaroxaban, a novel, investigational, oral anticoagulant, has a favorable risk-benefit profile for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip replacement or knee replacement surgery.

The advisory committee agreed by a 15-2 vote that the available clinical data demonstrate a favorable risk-benefit profile.

"The robust data from our clinical trials support the effectiveness of rivaroxaban in the prevention of dangerous blood clots following hip or knee replacement surgery," said Peter DiBattiste, M.D., Vice President, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. "We are very pleased that the advisory committee voted in support of the risk-benefit profile of rivaroxaban shown in our studies. We appreciate the thoroughness of the advisory committee's review and we will continue to work with the FDA as they finalize their review."

Data presented at today's advisory committee meeting included comprehensive results from the global RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program, including four pivotal Phase III studies that involved more than 12,500 patients. These studies compared oral rivaroxaban with injected enoxaparin for the prevention of DVT and PE in patients undergoing either total hip (RECORD1, 2) or knee (RECORD3, 4) replacement surgery. In a pre-specified pooled analysis of these trials, which included head-to-head comparisons with enoxaparin (RECORD1, 3 and 4) as well as a comparison of extended-duration (5 weeks) rivaroxaban with short-duration (2 weeks) enoxaparin (RECORD2), there was a statistically significant lower incidence in the primary efficacy endpoint (4.3% of rivaroxaban-treated patients and 9.4% of enoxaparin-treated patients, p<0.001) of total venous thromboembolism (a composite of proximal or distal DVT, non-fatal PE or death, any cause). Overall, rates of major bleeding, the primary safety endpoint, were less than 1% in the total treatment duration pool (0.4% of rivaroxaban-treated patients and 0.2% of enoxaparin-treated patients, p=0.0076).

J&JPRD submitted the NDA for rivaroxaban on July 28, 2008. If approved by the FDA, Ortho-McNeil will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts.

Unmet Needs in Venous Thromboembolism (VTE)

VTE includes DVT and PE. DVT is a blood clot in a deep vein (usually in the leg). These clots can break apart and travel through the bloodstream, blocking blood flow to vital organs. In the case of a PE, a blood clot traveled to and lodged in the lungs. PE can be a serious, life-threatening condition. Both DVT and PE are often preventable conditions.

Patients undergoing major orthopedic surgery may be at high risk for VTE because during hip or knee replacement procedures, the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of VTE. In fact, venous blood clots occur in 40-60% of patients undergoing major orthopedic surgery who do not receive preventive care. Each year, approximately 800,000 Americans elect to have hip and knee replacement surgeries, and VTE is the most common cause of re-hospitalization for this patient group.

About Rivaroxaban

The extensive program of clinical trials supporting possible approval of rivaroxaban by healthcare regulatory authorities makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. More than 60,000 patients are expected to enroll in the rivaroxaban clinical development program, which will evaluate the product in the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. Rivaroxaban is being jointly developed by J&JPRD and Bayer HealthCare AG.

Ortho-McNeil

Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals Inc. (OMJPI), a Johnson & Johnson company, is committed to providing innovative, high-quality prescription medicines and resources for healthcare providers and their patients in hospitals and other care facilities.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from OMJPI and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Neither OMJPI nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)

Source
Ortho-McNeil

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