FDA to weigh clinical cardiovascular trial standards for diabetic meds

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The FDA has arranged an Endocrinologic and Metabolic Drugs Advisory Committee meeting for two days next week to discuss whether long-term cardiovascular trials should be part of the approval process for pharmacological therapies developed for the treatment of diabetes.

The decision to hold the meeting follows severe warnings placed last year on GlaxoSmithKline’s Avandia and Takeda’s Actos diabetes pills, both of which were on the market for eight years before new trials raised concerns about associated cardiovascular (CV) risks.

The FDA hopes to establish a requirement for demonstrating CV benefit “will likely have major implications on the availability of new treatments for type 2 diabetes, because conclusive evidence of a reduced risk of macrovascular complications in type 2 diabetes has not yet been established for any of the currently available antidiabetic medications, including insulin.” In addition, the agency also said a requirement for long-term CV benefit would prompt questions as to why currently marketed therapies should remain available.

With this meeting the FDA said it will:

  • Establish a hurdle of long-term, costly trials to exclude CV harm may also affect drug development for type 2 diabetes, particularly if the mandate applies to every product, even those that have no suggestion of cardiotoxicity;

  • Discuss the role of CV assessment in the pre-approval and post-approval settings for drugs and biologics developed for the treatment of type 2 diabetes mellitus; and
  • Provide introductory material to prepare the advisory committee members for the scheduled presentations and ensuing discussion.

The advisory committee meeting is scheduled for two full days, and the panel will include the Endocrinologic and Metabolic Drugs Advisory Committee, diabetologists, cardiologists, statisticians and members of the Drug Safety and Risk Management Committee.

During the first day, experts in the field of diabetes and cardiology will present background information that will lay the foundation for extensive discussion among committee panel members, the FDA said. During the second day, the advisory committee meeting will be reserved for an extensive discussion among the advisory committee members.