BioCentury
ARTICLE | Regulation

Victoza rat's nest

April 6, 2009 7:00 AM UTC

Last week's FDA advisory committee meeting on Victoza liraglutide from Novo Nordisk A/S took an unexpected turn, with a preclinical thyroid cancer signal rather than cardiovascular risk falling into place as the stumbling block on the path to an approval recommendation.

Going forward, Novo Nordisk's ability to get Victoza approved in the U.S. will depend on its ability to persuade FDA to overcome precedent by approving a compound that causes tumors in both genders of two species at exposure levels close to human dosing. The agency also must be convinced that elevated calcitonin seen in clinical trials of Victoza - a biomarker of thyroid C cell hyperplasia and medullary thyroid carcinoma - are not signs of a process that eventually will lead to cancer...