Wednesday, May 22, 2013

UPDATE: 16 YES VOTES -- We're Monitoring FDA Advisory Committee Meeting On Suvorexant: Unfolding As Expected

05.23.13 @ 4:42 PM EDT | UPDATE | I've put together some "day after" analysis, under that link, there.

As expected, most of the healthy skepticism centers around dosing levels -- not overall safety, or efficacy. You can follow along here, by logging in as a "guest" -- no password or email needed.

4:35 PM EDT | UPDATE | VOTE 8 against suvorexant's automatic up-dosing, at 30/40 mg dosing, if no improvement seen at lower doses (15 mg) -- 7 vote for higher doses -- 2 abstaining. So Merck may have labeling warnings, as to the higher doses.

4:14 PM EDT | UPDATE | VOTE 13 in favor of suvorexant's safety at 15 mg dosing -- 3 vote against -- 1 abstaining. So Merck may well get it across the finish line unchanged, on dosing -- labeling looks to be where this is sorted out.

3:36 PM EDT | UPDATE | VOTE 11 vote against new 10 mg efficacy studies -- 5 in favor of new studies -- 1 abstaining. So Merck need not do additional studies -- the dose discussion continues -- labeling may be where this is sorted out.

2:53 PM EDT | UPDATE | VOTE 16 in favor of approval -- 0 against -- 1 abstain -- on the question of "sleep maintenance". So Suvorexant is approvable -- now the dose discussion begins.

2:50 PM EDT | UPDATE | VOTE 12 in favor of approval -- 4 against -- 1 abstain -- on the question of "sleep onset". So Suvorexant WILL reach the US market, in a about a month.

2:40 PM EDT | UPDATE | There is a move toward separating the approvability vote into a "sleep onset" and "sleep maitenence" votes -- essentially suggesting two separate indications will be voted upon, at 4:30.

In either case, it does seem that there is a visible majority of committee members who are leaning toward recommending approvalbility (on one or both indications) -- but likely with some suggestions about lower dosing, to start.

I will post the outcome of the vote, around 4:30 PM EDT. And although the full FDA Commission is not required to follow the Advisory Committee's views, they usually do. I do continue to see a 2013 approval date in the US for Suvorexant.

I also see only modest sales uptake, given the number of generic competitors in the sleep aid space.

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