The FDA has approved Welchol (colesevelam HCl, from Daiichi-Sankyo) as an adjunct to diet and exercise to reduce low-density lipoprotein (LDL-C) levels in boys and postmenarchal girls, 10–17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy. This approval was based on data from an eight-week, multicenter, randomized, placebo-controlled clinical study evaluating the efficacy of Welchol tablets as monotherapy or in combination with a statin in boys and postmenarchal girls 10–17 years of age, who were either treatment naive or on stable background statin therapy.
Additionally, the FDA has approved Welchol (colesevelam HCl) for Oral Suspension. In addition to the pediatric indication, Welchol tablets and oral suspension are indicated for use as an adjunct to diet and exercise in adults to reduce elevated LDL-C in primary hypercholesterolemia (Fredrickson Type IIa), alone or with a statin. Welchol is also indicated for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in combination with metformin, sulfonylureas, or insulin.
For more information call (877) 437-7763 or visit www.welchol.com.