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NEW CONGESTIVE HEART FAILURE DRUG RECEIVES FDA APPROVAL

 MANOPLAX (flosequinan) from Boots Pharmaceuticals, Inc.,
 Represents First New Class of Heart Failure Drugs in a Decade
 LINCOLNSHIRE, Ill., Dec. 31 /PRNewswire/ -- Boots Pharmaceuticals, Inc., announced today that it received approval from the U.S. Food and Drug Administration (FDA) to market MANOPLAX (flosequinan), for the treatment of congestive heart failure (CHF).
 Developed by Boots Pharmaceuticals, a division of The Boots Company PLC, of Nottingham, England, MANOPLAX is the first direct- acting, oral arterial and venous vasodilator approved in the United States for the treatment of congestive heart failure. An IP3 (inositol triphosphate) attenuator, MANOPLAX decreases the release of intracellular calcium resulting in relaxation of vascular smooth muscle, thus reducing the pumping load of the failing heart. As such, MANOPLAX alleviates fatigue and shortness of breath that typically characterize heart failure and helps to improve the patient's ability to perform every day functions.
 "MANOPLAX enables CHF patients to resume even the simplest activities such as shopping, climbing a flight of stairs or walking," said Milton Packer, M.D., professor of medicine, College of Physicians & Surgeons of Columbia University in New York.
 MANOPLAX, a convenient once-daily tablet, is indicated for the management of congestive heart failure in patients not responding adequately to diuretics (with or without digitalis) who either cannot tolerate an angiotensin-converting enzyme (ACE) inhibitor or who have not responded adequately to a regimen including an ACE inhibitor.
 "Flosequinan causes an increase in the cardiac output, that is, the amount of blood the heart pumps to the rest of the body. A decreased cardiac output leads to shortness of breath and the leg swelling that many CHF patients experience," Dr. Packer added.
 Studies involving approximately 2,200 patients showed MANOPLAX enabled patients to be more active than when on conventional therapy. MANOPLAX therapy has been shown to increase exercise capacity, and in some studies has been shown to improve New York Heart Association class status and CHF symptoms.
 CHF is an incurable and ultimately fatal chronic condition that affects nearly 3 million people in the United States and approximately 15 million worldwide. CHF is marked by a significant decrease in the heart's ability to pump and increased vascular resistance and fluid retention in the patient's body. The failing heart is unable to deliver adequate blood flow to supply the body's needs, which eventually leaves the patient bedridden as the disease progresses.
 Despite medical advances, mortality is greater than 50 percent for most CHF patients within five years of their initial diagnosis. The effect of MANOPLAX on survival is unknown at this time. In the Untied States, CHF is now the number one hospital discharge diagnosis for patients 65 years and older; more than 400,000 new cases and 900,000 total hospitalizations are reported each year.
 Side effects of MANOPLAX include headache, increased heart rate and a small incidence of liver function abnormalities. A slightly increased incidence of hypotension has been observed when MANOPLAX is added to ACE inhibitor therapy.
 MANOPLAX will be available for physician prescribing in March 1993 through a national joint marketing effort between Boots Pharmaceuticals, Inc., of Lincolnshire, and the Parke-Davis Division of Warner-Lambert Company, Morris Plains, N.J.
 MANOPLAX is the first product from the Boots cardiovascular research program, one of the company's five broad therapeutic areas of discovery and development. Additional research and development initiatives include: central nervous system, endocrinology/metabolism, rheumatology (pain relief/anti- inflammatory) and immunology.
 Headquartered in Nottingham, The Boots Company PLC last year (fiscal year ending March 31, 1992) had annual sales of 3,655.7 million pounds. A division of The Boots Company in Nottingham, Boots Pharmaceuticals sells and markets pharmaceutical products through subsidiaries in 20 countries and has manufacturing operations in 10 international markets. Boots Pharmaceuticals, Inc., headquartered in Lincolnshire, is the U.S. subsidiary of Boots Pharmaceuticals and operates manufacturing facilities in Shreveport, La.; Jayuya, Puerto Rico; and Kingstree, S.C.
 -0- 12/31/92
 /NOTE: Full prescribing information for MANOPLAX (flosequinan) is available by calling 800-452-5746, or in Washington, 202-467-3930.
 MANOPLAX is a registered trademark./
 /CONTACT: Ken Rabin, Ph.D., or John Seng, 202-467-3903, for Boots Pharmaceuticals; or Tom Thurman of Boots Pharmaceuticals, 708-405-7434/


CO: Boots Pharmaceuticals, Inc. ST: Illinois IN: MTC SU:

MH -- DC010 -- 0954 12/31/92 14:58 EST
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Date:Dec 31, 1992
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