Eli Lilly Shares Principles on Accelerated Approval Program

Eli Lilly and Company ranked No. 5 on the Fair360 Top 50 Companies for Diversity list in 2023.

 

Eli Lilly’s Accelerated Approval Program is a drug development pathway that advances innovation and provides early access to safe and effective therapies.

On average, developing a new medicine and bringing it through clinical trials can take up to 15 years. Many diseases lack treatments, therapies or cures, and waiting a decade for treatment could be the difference between life and death. The Accelerate Approval Program aims to help bring innovation to patients sooner, saving the lives of patients.

Concerns have been raised about the program, so Eli Lilly shared its guiding principles to ensure patients that the company is committed to doing what’s right.

“We firmly believe in the goal of the accelerated approval pathway — namely ensuring people living with unmet medical needs have timely access to safe and effective therapies,” the company wrote. “But to have confidence in the medicines approved under the Accelerated Approval Program, there must be confidence in the underlying pathway.”

Eli Lilly is committed to:

  • Providing timely access to FDA-approved, safe and effective new medicines for patients with unmet need
  • Transparency
  • Expeditiously produce confirmatory trial data

And, If confirmatory studies fail to verify the benefit, Lilly will promptly initiate discussions with FDA to determine the appropriate next steps.

Click here to read more about the principles.