Important News Due From FDA Tomorrow Afternoon — J&J’s Invokana®, Januvia® Competitor?

MRK-Inkovana-2013 Late in the afternoon tomorrow, after the markets have closed early — for Good Friday — we ought to learn whether the full Commission of the US FDA has voted to approve J&J’s canagliflozin candidate, a first-in-class SGLT2 inhibitor, for Type II diabetis treatment.

In January 2013, the Advisory Panel voted to recommend approval, to the full Commission.

To be branded as Invokana®, the J&J drug — if approved — will go head-to-head with Merck’s Januvia® franchise. That overall diabetis market — worldwide — is estimated at about $24 billion this year, growing to $36 billion by 2017. At present, the Januvia/Janumet franchise generates about $5.8 billion worldwide, in annual sales for Merck. If approved, over the next 24 months, I would expect to see Merck’s sales flatten out, and perhaps even begin to decrease a bit — back to around the $5 billion a year level, as Invokana ramps up — to about $500 million per year in sales by mid-2014 or so. Longer term, and this is simply a guess, Invokana could be a $4 billion a year franchise for J&J — into 2016 and beyond.

Why? Because earlier, Invokana soundly beat Januvia in a 10,000 patient head to head trial, for efficacy. It must also be noted, however though, that another maker’s drug, in this new class of SGLT2 inhibitors, showed a cardio-vascular safety signal. Thus far, that signal hasn’t appeared in any significant way in J&J’s Invokana candidate. So, it will be an interesting horse race, as Invokana seems not to be associated with the weight gains diabetics experience — while on Januvia (and the rest of the current class of medicines).

We will — of course — cover the full FDA’s decision, right here, tomorrow afternoon.

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