by Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP
On June 14, 2013, FDA issued the Guidance “Codevelopment of Two or More New Investigational Drugs for Use in Combination.” The guidance discusses FDA’s recommendations for developing an entirely new combination therapy where none of the drugs to be used in combination have been previously developed. FDA notes in the guidance that the recommendations do not apply to combination therapies involving previously developed drugs, or the combination of a new drug with a previously developed drug. While codevelopment has generally been centered in oncology and infectious disease, FDA’s guidance is intended to address codevelopment from a high-level, making it applicable to other diseases.
The complexity of certain diseases, such as cancer, cardiovascular disease, and infectious diseases, presents unique challenges to medicine. As scientific understanding of pathophysiological processes has increased, development of combination therapies has become increasingly possible. The potential benefits of combination therapies include improving treatment response by directing treatments at multiple therapeutic targets, minimizing development of drug resistance, and countering drug side effects and adverse events.