BREAKING: FDA Advisory Committee Vote: Invokana Should Be Approved

Not terribly surprising -- and we still need to wait for a full commission vote, but in as few as six weeks' time, Januvia should prepare to compete head to head with Invokana.

The FDA Advisory Panel just voted, 10-5, to recommend that FDA approve this new drug candidate for adults with Type-2 diabetes.

Beware what that portends for Januvia -- and Whitehouse Station. This is now Merck's biggest selling franchise.

UPDATED: FDA Advisory Committee Proceedings Going Well For Janssen Pharma

The committee meeting is now on lunch break, until 1:30 p.m. Eastern -- but the morning session went quite well, from Janssen's perspective, I thought. Here are today's background materials, from FDA.gov, as a PDF file.

I'd be pretty confident that Invokana^TM will see a majority committee vote for approval, later this afternoon/this evening. Of course, the advisory committee is just that -- advisory. And so, the full commission at FDA could choose to ignore the committee vote. But it only very rarely does.

So. . . Whitehouse Station ought to buckle-up -- now that Singulair^® has gone generic, it is true that Januvia^® is the single largest seller in Merck's 2013 portfolio, quarter by quarter. And that may see substantial erosion next quarter, if J&J/Janssen is ready to lauch Invokana on approval day. And you may bet that J&J is.

As ever, do stay tuned.