Welchol(R) (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia

Daiichi Sankyo, Inc. (DSI) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol=AE (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy. Originally approved in 2000 for LDL-C lowering and in 2008 for A1C reduction in adults, Welchol is approved as an adjunct to diet and exercise to reduce elevated LDL-C in adults with primary...

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