Generic Drug Repurposing for Common Diseases: Proposal and Design of a Pull Mechanism

Project Report

Generic Drug Repurposing for Common Diseases: Proposal and Design of a Pull Mechanism

Background

As research and development (R&D) costs for novel drugs have increased, some view drug repurposing as a faster and cheaper option. Drug repurposing seeks to identify new indications through research on already-approved drugs. Estimates of the average cost of bringing a new drug to market range from $1.5 billion to $2.5 billion.1,2 Conducting clinical trials and getting a drug to market can take on average 10.5 years — often longer when discovery and preclinical phases are included.3 In contrast, research and marketing for repurposed drugs may cost around $300 million and can be completed in as few as three years.4,5 Drugs targeted for repurposing have demonstrated safety in people through clinical trials and have amassed substantial real-world evidence while on the market. The combination of evidence generation during clinical trials and in real-world settings establishes well-defined safety and efficacy profiles. Therefore, developers of repurposed drugs may bypass early stages of testing and instead focus on demonstrating efficacy for a new indication.

Continue reading here.

Duke-Margolis Authors

Beth Boyer headshot

Beth Boyer, MPH

Policy Research Associate

External Authors

Damope Fawole, Duke Global Health Institute

Coralei Neighbors, Duke Department of Population Health Sciences

Armand Zimmerman, Duke Global Health Institute