FDA Issues Complete Response Letter for Rivaroxaban
RARITAN, N.J.--(BUSINESS WIRE)--Ortho-McNeil announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for rivaroxaban, an oral, once-daily anticoagulant. The NDA, filed in July 2008 by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) on behalf of Ortho-McNeil, seeks approval to market rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.
Ortho-McNeil is currently evaluating the FDA's complete response letter, and will respond to the agency's questions as quickly as possible. The FDA has not requested that any new clinical or non-clinical studies be conducted evaluating the efficacy or safety of rivaroxaban for this indication as a prerequisite for approval.
"We are confident in the positive benefit-risk profile of rivaroxaban and will promptly address the questions set forth by the FDA," said Peter DiBattiste, M.D., Vice President, Johnson & Johnson Pharmaceutical Research and Development.
On March 19, 2009, the FDA's Cardiovascular and Renal Drugs Advisory Committee agreed by a 15-2 vote that the available clinical data for rivaroxaban demonstrated a favorable benefit-risk profile.
The extensive program of clinical trials supporting possible approval of rivaroxaban by health care regulatory authorities will make rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. More than 65,000 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, 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.)