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12:00 AM
Jul 19, 2004
 |  BioCentury  |  Product Development

New stopwatch for PPAR developers

FDA's new guidance concerning the timing of two-year carcinogenicity studies for peroxisome proliferation activated receptor (PPAR) agonists could re-level the playing field, delaying development of compounds in mid-stage clinical development without holding up compounds in early clinical development.

As a result of the guidance, partners Ligand Pharmaceuticals Inc. and Eli Lilly and Co. last week announced that the development timeline of naveglitazar (LY818) would be delayed 18-24 months. The guidance states that clinical studies of PPAR agonists lasting longer than six months are not permissible until two-year rodent carcinogenicity studies are completed and submitted.

According to LGND (San Diego, Calif.), FDA's requirement for two-year rodent carcinogenicity studies is not new - the...

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