Shots:

• The two P-III studies involve assessing of VX-445 + tezacaftor + ivacaftor vs triple PBO & PBO + tezacaftor + ivacaftor in 405 & 108 patients with one F508del mutation + F/MF & two F508del mutations respectively
• The two P-III studies resulted in meeting its 1EP as improvement in lung function (ppFEV1) (13.8% & 10%) respectively and is safe- effective and tolerable
• Vertex plans to submit NDA to US FDA in Q3’19 and MAA to EU in Q4’19 for VX-659 or VX-445 triple combination therapy based on clinical studies

Ref: Vertex | Image: Vertex