UPDATE: 16 Yes Votes | We’re Monitoring FDA Advisory Committee Meeting On Suvorexant: Unfolding As Expected

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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