Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

FDA Committee Votes 16-0 For Approval Of Novo Nordisk Diabetes Treatment

By Novo Nordisk A/S | October 20, 2017

Novo Nordisk receives positive 16-0 vote from FDA advisory committee in favor of approval for semaglutide.

Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes. One member of the committee abstained.

Based on the data contained in the New Drug Application (NDA) for semaglutide, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to demonstrate the efficacy and safety profile of semaglutide for the treatment of type 2 diabetes in adults. 

The recommendation for approval was based on data from SUSTAIN, a comprehensive global development program that evaluated the safety and efficacy of semaglutide, administered once-weekly. The global SUSTAIN Phase 3a clinical trial program comprised eight clinical trials (one of which was a 2-year cardiovascular outcomes trial), involving more than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease. 

“Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “We look forward to continuing to work with the FDA as they complete their review of semaglutide.” 

The NDA for once-weekly semaglutide was submitted to the FDA in December 2016 under the U.S. FDA’s Prescription Drug User Fee Act V (PDUFA V) regulation. Semaglutide is currently also under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency. 

About Advisory Committees

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee’s recommendation, but it takes its advice into consideration when reviewing data concerning the safety and efficacy of marketed drugs or new drug applications.

(Source: Novo Nordisk A/S)

Related Articles Read More >

FDA logo
Ultra Supplement announces recall for undeclared tadalafil
analyzing medical sample
Expert answers to nitrosamine impurity questions
Cardinal Health
Cardinal Health announces $124M settlement of investors’ opioid suit
FDA logo
FDA warns four companies over selling honey tainted with prescription drugs

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards