• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Novo Nordisk seeks FDA nod for oral diabetes pill

March 21, 2019 By Sarah Faulkner

Novo Nordisk - updated logoNovo Nordisk (NYSE:NVO) said this week that it submitted applications to the FDA for its oral formulation of semaglutide, a once-daily glucagon-like peptide-1 receptor agonist therapy.

The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also submitted for approval of an indication related to risk reduction of major adverse cardiovascular events.

For the blood sugar control indication, Novo Nordisk submitted a priority review voucher and reported that it expects to hear back from the FDA within six months.

Novo Nordisk’s oral semaglutide has been studied in clinical trials involving 9,543 adults with Type 2 diabetes.

The company also filed a supplemental application for its once-weekly Ozempic semaglutide injection, going after an indication to reduce the risk of major adverse cardiovascular events. The FDA approved Ozempic for adults with Type 2 diabetes in Dec. of 2017.

“We are very excited about these three regulatory filings with the FDA as they represent a significant milestone for the company, but most importantly represent new potential treatment options for adults living with type 2 diabetes,” VP & CMO Todd Hobbs said in prepared remarks.

“We know that many adults with type 2 diabetes are still struggling to control their blood sugar and are at increased cardiovascular risk. We hope that, if approved, these products can help those patients,” he added.

Last month, Glooko announced that it teamed up to connect Novo Nordisk’s insulin pens with the company’s diasend diabetes management solution.

Novo Nordisk plans to launch its connected insulin pens, the NovoPen 6 and NovoPen Echo Plus, in early 2019. Any provider using diasend and any person using the diasend mobile app will be able to sync data from Novo Nordisk’s connected pens, according to Glooko.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Diabetes, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Wall Street Beat Tagged With: Novo Nordisk

IN CASE YOU MISSED IT

  • Glucotrack to effect a reverse stock split
  • Medtronic unveils ‘MiniMed’ as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes
  • Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7
  • Tandem, Abbott strike deal to pair insulin pumps with glucose-ketone monitor

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. 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 | RSS