Novo Nordisk May Use Priority Review Voucher To Speed Oral Semaglutide To Market

 
• By Sten Stovall

Novo Nordisk’s chief science officer tells Scrip the readout of its PIONEER 6 trial on oral semaglutide came earlier than originally thought, allowing for an FDA filing in first-half 2019, and that use of a priority review voucher is a clear option that could speed up the process.  

Diabetes
PIONEER 6 Readout Has Accelerated Filing Timeframe For Oral Semeglutide • Source: Shutterstock

The last of Novo Nordisk AS's 10 PIONEER clinical development program trials - PIONEER 6 - has read out early with good results, allowing the Danish diabetes fighter to file its oral GLP-1 semaglutide in the first-half of the new year, earlier than previously expected, chief science officer Mads Krogsgaard Thomsen told Scrip.

Thomsen, who has been with the Danish group for more than 25 years, also said Novo Nordisk may use a priority review voucher to hasten the regulatory approval process

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
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.