FDA Streamlines Review for Drug Combinations

The Wall Street Journal Health Blog reported that the FDA issued a draft guidance for the drug industry “designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses.” This is exciting news for TB drug development, since there is the potential to reduce the time to develop and obtain approval for new regimens by several years.

The guidelines indicate that codevelopment of drugs should be done based on the following criteria:

  • The combination will treat a serious disease or condition.
  • There is compelling biological rationale, for example, the compounds act on the different targets in the same molecular pathway.
  • Preclinical testing or early clinical studies show greater activity or longer response with the combination than with the compounds individually.
  • There is good justification of why the compounds can not be developed individually, for example, the development of drug resistance as is the case in TB.

The FDA is accepting comments from the public until February 14, 2011 with a final version hopefully released by June 2011. Send comments to the following address referencing Docket No. FDA-2010-D-0616:

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852.

If you have questions, contact Colleen Locicero (CDER) at 1-301-796-1114.

Additional Coverage:

Bloomberg News

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