This Evening, Merck's Sublingual Ragweed Treatment, MK-3641, Earned A 6-2 Nod, From FDA Advisory Panel

As ever, the committee's vote does not bind the full Commission, but this was just about as, erh. . . sunny an outcome as Whitehouse Station could have hoped for -- from this particular panel, for some standardized allergen extract, short ragweed (Ambrosia artemisiifolia), which "melts in your mouth" [heh!] -- and is proposed to be branded as Ragwitek^®. The biologic candidate is not likely to crack the $500 million a year mark (a half blockbuster), in my opinion, but if approved, it will definitely be a nice franchise, just the same. [UPDATED, for an alternate one-liner -- per my witty commenters below: ". . .is not likely to crack the $500 million a year mark (a half blockbuster), but that's nothing to sneeze at, either!" Heh!]

Go read all about the to and fro at the committee, over at MedScape online -- but here's an interesting bit:

. . . .The FDA accepted the biologic license application (BLA) for Ragwitek in May 2013. Merck's BLA included data from 5 clinical studies in adults aged up to 85 years. The committee vote was partially split, however, because the 2 phase 3 efficacy studies involved only persons aged up to 50 years, and not people aged 50 to 65 years, for which approval has been requested. . . .

With 9 members of the advisory committee voting, 6 voted yes that the data provided evidence of efficacy, 2 voted no, and 1 abstained. Those 3 members, however, agreed that if the language of the question they were asked to vote on had been restricted to people aged up to 50 years, they would have voted yes. . . .

So -- in about six weeks, it ought to get a final full FDA green light. The likely only open question -- at this point -- is whether the full FDA will aprove it through age 65 -- or just through age 50 (for which there are solid data points).