FDA Offers Communication On Januvia® — No Reason To Be Alarmed, In My Opinion

We have been following this set of stories since 2009, as regular readers know. And I think Merck will be okay, here — I think its Januvia® franchise will be just fine. This same unpublished data was covered by this last post of mine — prior background, here.

While it is always possible that some surprising pre-cancerous cells finding will turn up, I wouldn’t think it probable, at this point. Moreover, if it involves Merck’s Januvia/Janumet franchise — it is likely to involve the entire class of these drugs. And so, all ships in the harbor will rise and fall with the same tides.

Again, it is responsible science to monitor and evaluate all new data, at FDA — but I wouldn’t be an alarmist here. The pre-cancerous cells scare is likely just that — a scare, not a signal.

I am quite-likely the last man on Earth to consider drinking any Whitehouse Station Kool-Aid, but I do know it takes many months to sort these things out (I am a man of science, afterall). And FDA has previously reviewed reams of data on this class of drugs. The putative cancer signal was all but ruled out, back then. There is little reason to expect anything terribly different, this time.

Just the same, here is the FDA’s announcement of this morning:

. . . .FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.

FDA previously warned the public about postmarketing reports of acute pancreatitis, including fatal and serious nonfatal cases, associated with the use of the incretin mimetic drugs exenatide1 and sitagliptin. A recently published study that examined insurance records also found the use of exenatide or sitagliptin could double the risk of developing acute pancreatitis. The Warnings and Precautions section of the drug labels and the patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. . . .

As ever, we will keep an eye on this — but I would not be terribly alarmed here. All of this has been known in some form, for some time — so the NYSE downdraft in Merck’s stock is likely an overreaction, in my opinion.

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