Today’s FDA Meeting: An Important, And Nerve-Wracking Moment, For Merck’s Januvia® Franchise

An FDA Advisory Committee meets today to make final recommendations on Janssen/J&J’s next-gen diabetes drug candidate, to be branded as InvokanaTM — backed by a massive 10,000 patient clinical trial data set — it soundly bested Merck’s Januvia® in a head to head trial.

It should be noted, though, that another drug-maker’s candidate (in the same SGLT2 inhibiting class) showed a safety signal. That’s the central question for today’s panel: was the other drug’s signal material enough to warrant additional study data, for this drug of the same class — or was that an artifact unique to the other drugmaker’s drug, and thus not likely to ultimately appear in the J&J candidate? There will be a committee vote, up or down, by day’s end.

In any event, it is certainly true that Whitehouse Station will be listening in. Why? beacause, if Invokana is approved by FDA in a few weeks’ time — the Merck Januvia franchise, its second biggest seller overall, will be at material risk of erosion.

Per Endocrine Today, then — do go read it all:

. . . .The FDA Endocrinologic and Metabolic Drugs Advisory Committee will today discuss the new drug application for canagliflozin, which has been developed as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. . . .

In addition, Invokana, the new J&J candidate, seems to avoid some of the obesity risk present in the older medication regimes (or, it may actually offer a weight-loss on-drug effect — etiher way, that would be very good news).

This all may leave Merck only about 2 to 3 months of remaining consistency in the diabetes space — for Januvia/Janumet.

We shall see.

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