European Med Agency Sees No Need To Change Januvia® (Sitagliptin) Label

With all my goofy and sundry tech issues now solved, I may return to the usual pitter-pat about Whitehouse Station’s fortunes.

This is about four days out of date, now — but Ed, over at Pharmalot covered it well, in my downtime — noting that despite one study (with some methodological problems) pointing the other way, the European Medicines Agency has concluded that there is no reliable evidence to suggest that diabetis drugs in the class of sitagliptin, or Merck’s Januvia®/Janumet® brands (if you prefer) — are driving elevated pancreatic cancer risks in patient populations studied.

Do go read all of Ed’s report — but here is a bit:

“. . . .Data from clinical trials do not indicate an increased risk with these medicines. However, the number of events is too small to draw final conclusions. Due to their mechanism of action, some uncertainties remain in respect to the long-term effect of these medicines on the pancreas and more data collection efforts are under way,” the CHMP concluded. . . .

The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia, which is the biggest seller in this group. . . .

We will keep an eye on this, but it is good news for Whitehouse Station. Speaking of sitagliptin, we still have seen no Indian MSM report on the outcome of the Glenmark patent hearing, there. We will keep a weather eye on the horizon for that, as well. Now, go enjoy your Sunday!


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