The approval of Welchol for pediatric patients with heFH is based on data from an eight-week, multi-center, randomized, placebo-controlled clinical study, which evaluated the efficacy of Welchol tablets (1.875 or 3.75 g/d) as monotherapy or in combination with a statin. The study was conducted with boys and postmenarchal girls 10-17 years of age, who were either treatment naive or on stable background statin therapy.

Welchol for Oral Suspension

The FDA also approved Welchol?® (colesevelam HCl) for Oral Suspension, providing an alternative to the current tablet formulation. Welchol for Oral Suspension is indicated as an adjunct to diet and exercise to improve both glycemic control in adults with type 2 diabetes mellitus, and to reduce elevated LDL cholesterol in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (a statin). Welchol for Oral Suspension is also indicated for use as an adjunct to diet and exercise for the reduction of elevated LDL-C in boys and post-menarchal girls, 10 to 17 years of age, 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 once daily.

SOURCE Daiichi Sankyo, Inc.