Report: FDA comfortable with EMA's diabetes conclusions
Regulatory concern that diabetes medications known as incretin mimetics could be linked to pancreatic cancer may have eased a bit. Trade publication BioCentury is reporting that the FDA “concurs” with the European Medicines Agency that the medications and disease are not linked. The EMA's Committee for Medicinal Products for Human Use announced July 26 that “presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines.” The drugs in question include GLP-1 inhibitors like Novo Nordisk's Victoza, as well as DPP-IV drugs like Merck's Januvia.
The FDA was not able to confirm the report at press time. [UPDATE: The FDA's Center for Drug Evaluation and Research tells MM&M that the regulator and the EMA had been in touch regarding the EMA's analyses, and says "our general view is that their conclusions are consistent with our current understanding of the data." CDER says the FDA also says the current GLP-1 labels reflect "the extent of our understanding of the safety signals at this point in time." The FDA's GLP-1 study is ongoing, and CDER says an epidemiological study is also in the works.]
CHMP's issue was that the data which appeared to indicate a link had limitations and an underlying potential for bias, as well as differences in age, gender and disease duration among the test subjects, all of which the regulator wrote “preclude a meaningful interpretation of the results.”
ISI Group analyst Mark Schoenebaum told MM&M at the time that the read-through in terms of the potential impact this decision could have on the US was unclear, but that it wasn't a bad thing. In a July 26 investor note, he called the concern a “$3 hole” in Merck shares, and wrote today that BioCentury's news makes him consider “this overhang as largely dead.”
Merck's Tuesday Q2 earnings call did not indicate any concern about the EMA's scrutiny, or even its recent conclusion that fear surrounding DPP-IVs was overrated. In fact, sales of the Januvia and Janumet rose during the quarter, before the EMA weighed in. Further, Merck noted that generics don't pose a threat to these DPP-IVs because these drugs are generally used as a second-line treatment for patients who aren't able to adequately control their condition with cheaper metformin.The lack of a clear financial impact should not be surprising -- the American Diabetes Association told MM&M in March that it had not been flooded with patient calls. Leerink Swann analyst Seamus Fernandez was also unperturbed by the report, writing in February "we are skeptical that this study alone will have any meaningful impact on use of these therapies.”