Vertex Submits Triple Combo to the FDA for Approval, What Happens Next?

We’re getting closer to the finish line! It was announced early this morning that Vertex submitted a New Drug Application to the FDA! Vertex also submitted for a priority review, which, if accepted, “would shorten the FDA’s review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months from submission.

The FDA’s timeline is anyone’s guess (it also remains to be seen if the priority review will be accepted), but we do have precedent to follow when we look at some of Vertex’s other drugs in the review process. Thanks to www.drugs.com (hilarious website name) for keeping a timeline:

Kalydeco:

Oct 26, 2011: Vertex submits NDA and priority review to the FDA for Kalydeco

Dec 15, 2011: FDA grants priority review

Jan 31, 2012: FDA approves Kalydeco

Total time = 98 days

Orkambi:

Nov 5, 2014: Vertex submits NDA and priority review to FDA for Orkambi

May 12, 2015: FDA advisory panel votes 12 to 1 to recommend approval of Orkambi

Jul 2, 2015: FDA approves Orkambi

Total time = 240 days (7 months 28 days)

Symdeko:

July 26, 2017: Vertex submits NDA and priority review to FDA for Symdeko*

Nov 3, 2017: FDA grants priority review

Feb 12, 2018: FDA approves Symdeko

Total time = 202 days (6 months 18 days)*

It’s worth noting that all of the NDA’s were accepted for priority review and did make it across the finish line before that 8-month mark, with Kalydeco doing it in a breath taking (CF pun) 98 days, and an average of 180 days* (5 months) between all three.

The huge success of the phase III trial for VX-445 (elexacaftor) in combination with tezacaftor and ivacaftor has been widely reported, and closely resembles Kalydeco’s results. Today’s news should give all of us reason to be enormously hopeful!

@FDA… don’t screw this up.


*A correction was applied to the above timeline