1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Secukinumab Phase III Data Look Reassuring Ahead Of Advisory Committee Review

 
• By Emily Hayes

Efficacy results look solid in pair of Phase III trials published in NEJM, but some question whether a double dose adds enough to get approval. Investigators note prevalence of Candida infections in patients on the Novartis drug.

Publication of full results of two Phase III trials for Novartis AG’s secukinumab in the New England Journal of Medicine paint a reassuring picture of safety and efficacy for the new wave of IL-17 class of biologics aimed at psoriasis and related conditions ahead of an FDA advisory committee meeting in the fall.

FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee will consider secukinumab for moderate-to-severe psoriasis on Oct. 20, the agency announced July 11.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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
Start Free Trial

Already a subscriber?

More from Clinical Trials

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

EMA Official Clarifies Benefits And Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

More from R&D

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.