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12:00 AM
Apr 06, 2009
 |  BioCentury  |  Regulation

Class warfare

In comments to the Endocrinologic and Metabolic Drugs Advisory Committee last week and in its briefing documents to the panel, FDA officials said preclinical C cell thyroid cancer signals detected by Novo Nordisk A/S in studies of its Victoza liraglutide therapy for Type II diabetes seem to be a class effect of long-acting GLP-1 agonists.

But not all carcinogenicity signals are of equal importance, and Amylin Pharmaceuticals Inc., whose exenatide once weekly is the next product in line for regulatory approval, says FDA has not asked for additional data and that it is on track to submit an NDA this quarter.

There are differences in the species and doses at which the signals have been seen, as well as in how the two compounds are metabolized that might play roles in FDA's assessment of Amylin's product.

Karen Mahoney, a clinical reviewer in FDA's Division of Metabolism and Endocrinology Products, told the panel that an animal signal similar to the effect Novo reported "is being noted in interim carcinogenicity data for some other long-acting GLP-1 analogs in development."

FDA's briefing document stated that "preliminary results from a rat carcinogenicity study of another GLP-1 receptor peptide agonist showed it increased the incidence of c-cell adenomas in males and females and the incidence of combined carcinomas and adenomas...

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