Vertex's VX-661 Has Positive Outlook Despite Futility Finding

Although a study testing a combo of the company's cystic fibrosis drug Kalydeco and the investigational VX-661 in patients with minimal CFTR function was ended due to futility, Vertex is on pace for a 2017 filing of the combo in three other CF subpopulations.

Vertex Pharmaceuticals Inc. revealed that a combination including one of its experimental cystic fibrosis drugs failed to show a significant benefit in one of the most challenging CF subpopulations, but three other Phase III trials of the combo are ongoing with an FDA filing anticipated in late 2017.

The company will terminate the study testing the combination of the firm's first marketed CF drug, Kalydeco (ivacaftor), and the new VX-661, Vertex announced Aug. 15 after the market closed

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Clinical Trials

More from R&D

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By 

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.