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 InvokanaTM 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.