FDA Approves New Formulation of Welchol for Adults with Type 2 Diabetes and High Cholesterol

Strategic Insights -

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Welchol (colesevelam HCl) for Oral Suspension, expanding treatment options for adult patients with primary hyperlipidemia and type 2 diabetes. Welchol, first approved in 2009, is the only product approved by the FDA to improve both glycemic control and LDL cholesterol in adults with type 2 diabetes and high LDL cholesterol. The new formulation allows for mixing with fruit juice or diet soft drinks, offering a more flexible dosing option for patients.

Key Takeaways:

  • Welchol for Oral Suspension is the first product approved by the FDA to mix with fruit juice or diet soft drinks, providing a new treatment option for adult patients with primary hyperlipidemia and type 2 diabetes.
  • The FDA has approved Welchol for Oral Suspension to improve both glycemic control and LDL cholesterol in adults with type 2 diabetes and high LDL cholesterol, making it a valuable treatment option for this patient population.
  • The new formulation of Welchol expands the indications for the drug, which was originally approved in 2000 for LDL-C lowering and 2008 for A1C reduction in adults.
  • Welchol has also been approved for a pediatric indication, specifically to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia.
  • Daiichi Sankyo, Inc. is confident that the new formulation of Welchol will help patients reach their LDL-C and A1C goals, citing patient appreciation for the flexible dosing options provided by Welchol.
  • The number of Americans affected by diabetes has increased, with over 25 million people diagnosed, and the American Diabetes Association emphasizes the importance of reducing both A1C and LDL-C levels for patients with type 2 diabetes.

Statistics:

  • Over 25 million Americans are affected by diabetes, with 90-95% of individuals having type 2 diabetes (1).
  • Every 21 seconds, another person is diagnosed with diabetes (2).
  • More than 50% of adults with type 2 diabetes also have elevated LDL-C (3, 4, 5).
  • The American Diabetes Association recommends targeting an A1C level of less than 7% and an LDL-C goal of less than 100 mg/dL for adult patients with type 2 diabetes (6).

Sources:

  • (1) American Diabetes Association
  • (2) American Diabetes Association
  • (3) American Diabetes Association and American College of Cardiology
  • (4) American Diabetes Association and American College of Cardiology
  • (5) American Diabetes Association and American College of Cardiology
  • (6) American Diabetes Association