Vertex Announces Acceptance of Applications for review of Tezacaftor/Ivacaftor

[jricci]

Vertex Announces Acceptance of its Applications for Review of the Tezacaftor/Ivacaftor Combination Treatment in People with Cystic Fibrosis by the FDA and EMA

-FDA grants Priority Review of the application and sets action date of February 28, 2018-

-Applications supported by positive results from two global Phase 3 studies in people with CF ages 12 and older who have two copies of the F508del mutation or one F508del mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor-

http://www.businesswire.com/news/ho...ations-Review-TezacaftorIvacaftor-Combination

 

[ToriMom]

Thank you for posting this great news!! Is this for the remaining residual function mutations? I am hopeful that these modulators move forward for everyone they can help...
Does this mean they would decide by February 2018 or look at the application at that time?
Michelle

 

[jricci]

Hi Michelle- They’ll review Tezacaftor/Ivacaftor (VX-661 studies) for those ages 12 years and older with DDF508 and those with one copy of DF508 and one copy of a mutation that is expected to have residual function (including a few splice mutations)
I'm not sure if February 2018 is when they’ll have a decision or if that ‘s when they start reviewing. I took it to mean that a decision would be made by February, but that's just a guess.

 

[Aboveallislove]

February 2018 should be decision.