This is good news for Merck — and even so, it would be wise to continue to monitor, at a by-patient level, the ongoing data stream. So FDA will. Adverse events will be reported; and the data should always be scanned for emerging patterns.
But this should help Whitehouse Station a bit, with Januvia® sales.
As I’ve said before, I did expect/predict this outcome: a relatively complete “all clear” signal.
Here is the irrepressible Ed Silverman, over at Pharmalot, on it all:
“. . . .The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman writes us. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the extent of our understanding of the safety signals at this point in time. FDA’s review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs. . . .”
Do stay tuned as J&J’s Invokana® diabetes franchise continues to make inroads, here — acting by a new, and differing mechanism. Invokana has posted clearly superior clinical trial results, but was only approved by FDA in March of 2013. We will watch this horse race unfold.