Susan Holz, public relations manager at Boehringer Ingelheim Pharmaceuticals, said in an earlier interview, "We are aware of the advisory committee’s concerns with dapagliflozin and are working with the FDA to ensure [that] our filing package for empagliflozin is robust and comprehensive. Phase III trials for empagliflozin are underway, and we are continuing to evaluate the drug’s safety profile." Currently, there are 11 ongoing, multinational, phase III clinical trials, including a large cardiovascular outcomes safety trial, she said.
At the EASD meeting in September, Dr. Michaela Diamant, scientific director of the diabetes center at Free University Medical Center in Amsterdam, commented that SGLT2 inhibitors have "an interesting mechanism that addresses, to a certain extent, a pathogenic defect that has been largely overlooked in diabetes. ... I’m sure there is a huge group of patients who can profit from these novel agents."
Regarding the safety issue, she asked, "If you would have a trial of 2-5 years, would you definitely address causality of cancer? We know that cancer development takes 20 years. It’s very unlikely that the drug caused cancer. We have to do what is feasible. The industry is not going to develop any more of these drugs if they are required to do a trial of 10 years. It’s difficult to tease out [contributors] to the development of cancer," Dr. Diamant continued.
Dr. Diamant has been a board member, advisory panel member, consultant, research support recipient, and/or speakers bureau participant for Eli Lilly, Merck Sharp & Dohme, Novo Nordisk, Abbott, AstraZeneca/BMS, Boehringer Ingelheim, Poxel Pharma, Sanofi-Aventis, Amylin Pharmaceuticals, Novartis, and Takeda.
Sue Sutter of "The Pink Sheet" contributed to this story. "The Pink Sheet" and this publication are both owned by Elsevier.