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| |  U.S. Food and Drug Administration Approves Pravachol (Pravastatin Sodium) for Use in Pediatric Patients PRINCETON, NJ -- October 31, 2002 -- Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Pravachol® (pravastatin sodium) for use in treating pediatric patients with heterozygous familial hypercholesterolemia (HeFH). The FDA approval of Pravachol for this new indication provides an additional treatment option for children ages 8 years and older who suffer from this condition and whose LDL cholesterol levels are above the indicated limits after an adequate trial of diet. Familial heterozygous hypercholesterolemia is an inherited disorder that causes very high cholesterol levels beginning at birth and significantly increases the risk of having a heart attack early in life. It is estimated that this condition affects 1 in 500 children. The FDA approval was based on the results of clinical studies that were conducted to assess the safety, efficacy and pharmacokinetic profile of Pravachol in this patient population. Bristol-Myers Squibb conducted these studies after receiving a written request from the FDA. In return for complying with the FDA request, Bristol-Myers Squibb was also granted a six-month extension to the company's exclusivity for Pravachol (pravastatin sodium) through April 2006. "Pravachol is one of the most extensively studied drugs of its kind and has a well established long-term safety profile," said Peter R. Dolan, Chairman and Chief Executive Officer, Bristol-Myers Squibb. "It is our hope that the FDA approval of this indication may help to extend the benefits of Pravachol to a younger patient population. In addition, the clinical studies that were conducted in this patient population serve to further reinforce the overall safety profile of Pravachol." As part of the Food and Drug Administration Modernization Act (FDAMA), Congress included provisions to encourage more investigation of the unmet medical needs of pediatric patients. One provision allows the Administration to request in writing that companies voluntarily conduct clinical studies to evaluate the use of their products in children. Companies that chose to comply with the written request are granted an additional six-month period of exclusivity following the submission of reports on completed pediatric studies that satisfy each aspect of the FDA's request. In accordance with FDAMA, Bristol-Myers Squibb conducted studies to determine the safety and efficacy of Pravachol (pravastatin sodium) in pediatric patients with heterozygous familial hypercholesterolemia. Pravachol is one of the most extensively studied drugs of its kind, and is the only member of the statin class that is indicated, in addition to diet, to reduce the risk of first and second heart attack as well as stroke in patients with elevated cholesterol or coronary heart disease when diet and exercise alone are not enough. The long-term efficacy of pravastatin therapy in children to reduce morbidity and mortality has not been established. Pravachol, a prescription drug, is not for everyone, including women who are pregnant or nursing or may become pregnant, or people with liver problems. Because serious side effects can result, patients should tell their doctor about any unexplained muscle pain or weakness they experience while on Pravachol, and about any other medications they are taking. Doctors may do blood tests to check for liver problems. Some mild side effects, such as slight rash or stomach upset, occurred in two to four percent of patients. Bristol-Myers Squibb is a $19 billion global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
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