Merck Receives 'Approvable' Letter from FDA on New Drug Application for ARCOXIA.WHITEHOUSE STATION, N.J. -- Merck & Co., Inc. today confirmed that it has received an "approvable" letter from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for ARCOXIA(TM) (etoricoxib). The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional safety and efficacy data for ARCOXIA are required. "We continue to believe that ARCOXIA has the potential to become a valuable treatment option for many Americans with arthritis and pain," said Raymond V. Gilmartin, chairman, president and chief executive officer, Merck & Co., Inc. "We plan to work with the FDA to address what steps need to be taken before the application may be approved." About ARCOXIA and Merck The company submitted a revised NDA to the FDA on Dec. 30, 2003, to include efficacy data for ankylosing spondylitis Ankylosing Spondylitis Definition Ankylosing spondylitis (AS) refers to inflammation of the joints in the spine. AS is also known as rheumatoid spondylitis or Marie-Strümpell disease (among other names). and to provide additional cardiovascular safety data. In the NDA, Merck is seeking indications for ARCOXIA for the treatment of osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. , rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , chronic low back pain, acute pain, dysmenorrhea dysmenorrhea Pain or cramps before or during menstruation. In primary dysmenorrhea, caused by endocrine imbalances, severity varies widely. Irritability, fatigue, backache, or nausea may also occur. (menstrual pain), acute gouty arthritis acute gouty arthritis Acute gout Rheumatology An abrupt gouty attack, which may be precipitated by overeating, alcohol, surgery, emotional stress, infection, antibiotics, insulin Clinical Crushing pain of a joint–most often the great toe–which is and ankylosing spondylitis. ARCOXIA has been launched in 48 countries worldwide in Europe, Latin America and the Asia-Pacific region. Merck will continue to work with regulatory agencies in the countries where ARCOXIA is approved, including the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. which recently announced plans for a safety review of the COX-2s, to assess whether changes to the prescribing information for this class of drugs, including ARCOXIA, are warranted. Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. ARCOXIA(TM) is a trademark of Merck & Co., Inc. Forward-Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any) which the company incorporates by reference. |
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