Merck Expects to File for Regulatory Approval of Experimental Combination Drug for Type 2 Diabetes Early

Strategic Insights -

Merck & Co. has accelerated its timeline for filing a regulatory application for its experimental combination drug MK-0431A, which aims to treat type 2 diabetes. The company had originally planned to file for approval in 2007 but now expects to submit its application to the U.S. Food and Drug Administration later this year. This move comes as the number of U.S. cases of type 2 diabetes has doubled in the past 15 years to 14.6 million, according to the Centers for Disease Control and Prevention.

Key Takeaways:

  • Merck & Co. expects to file for regulatory approval of MK-0431A, a combination drug for type 2 diabetes, later this year, accelerating its original 2007 timeline.
  • MK-0431A combines Merck's Januvia treatment, under review by the FDA, with metformin, a widely used generic medication that helps control blood sugar levels.
  • The combination drug is seen as potentially even more effective than Januvia, which lowers patients' blood sugar levels.
  • Type 2 diabetes accounts for more than 90% of all cases of the disease in the U.S. and has doubled in the past 15 years to 14.6 million cases, according to the Centers for Disease Control and Prevention.
  • Merck's Chief Executive Richard Clark identified diabetes as one of the company's nine health care areas of focus under its restructuring plan announced in December.
  • The company's shares fell 48 cents to $33.47 on Monday.

Statistics:

  • 14.6 million: The number of U.S. cases of type 2 diabetes, according to the Centers for Disease Control and Prevention.
  • 90%: The percentage of all diabetes cases in the U.S. attributed to type 2 diabetes.

Sources:

  • The Record, Hackensack, N.J. (c) 2006
  • Centers for Disease Control and Prevention (CDC)