Vertex Reports Positive Results of Triple Combination Therapy in P-III Studies for Cystic Fibrosis

 Vertex Reports Positive Results of Triple Combination Therapy in P-III Studies for Cystic Fibrosis

Vertex Reports Positive Results of Triple Combination Therapy in P-III Studies for Cystic Fibrosis

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

Click here to read full press release/ article | Ref: Vertex | Image: GMP News

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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