(dailyRx)
Daiichi Sankyo, Inc. has announced that the FDA has approved the supplemental new drug application for Welchol (colesevelam HCl) to be used as an adjunct to diet and exercise for reducing elevated low-density lipoprotein (LDL, or “bad” cholesterol) in children ages 10 to 17 with heterozygous familial hypercholesterolemia alone or in combination with a statin after failing an adequate trial of diet therapy.
Familial hypercholesterolemia (FH) is a genetic disorder resulting in elevated LDL and increased risk of heart disease. Some 10 million people have the disorder worldwide, the majority of whom have heterozygous familial hypercholesterolemia (heFH).
Welchol was approved in 2000 to lower LDL and in 2008 to reduce A1C (red blood cells with sugar attached, which in higher amounts can indicate poor blood sugar control and diabetes) in adults. The drug has also won FDA approval as an adjunct to diet and exercise to reduce elevated LDL in adults with primary hyperlipidemia (high cholesterol) and improve blood sugar control in adults with type 2 diabetes.
“The FDA approval of Welchol for children with inherited high cholesterol provides another important treatment option for these children, whose elevated LDL cholesterol puts them at increased risk for cardiovascular disease,” said Evan A. Stein, M.D., Ph.D., director of the Metabolic & Atherosclerosis Research Center in Cincinnati. “The pivotal trial of Welchol in this pediatric patient population demonstrated that Welchol, as monotherapy or when combined with a statin, significantly reduced [LDL].”
The approval of Welchol for pediatric patients with heFH is based on data from an eight-week, multicenter, randomized, placebo-controlled clinical study that evaluated how effective Welchol tablets (1.875 or 3.75 g/d) were alone or in combination with a statin. The study was conducted with boys and girls who’d started menstruation between the ages of 10 and 17 who were either new to treatment or were stable with the help of statin therapy.
The most commonly reported adverse reactions reported were inflammation of the nose and throat, headache, fatigue, an increase in creatine phosphokinase (an enzyme found mainly in the heart, brain and skeletal muscle), runny nose and vomiting.
Welchol for Oral Suspension
The FDA also approved a liquid formulation of Welchol. Welchol for Oral Suspension is indicated as an adjunct to diet and exercise to improve both glycemic control in adults with type 2 diabetes and to reduce elevated LDL in adults with primary hyperlipidemia alone or in combination with a statin.
Welchol for Oral Suspension is also indicated for use as an adjunct to diet and exercise for the reduction of elevated LDL in boys and postmenarchal girls ages 10 to 17 with heFH alone or in combination with a statin after failing an adequate trial of diet therapy. The recommended dose of Welchol for Oral Suspension is one 3.75-gram packet daily.
Contact:
Alyssa Dargento
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