Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Lilly, Amylin Resubmit Bydureon Application

By Drug Discovery Trends Editor | July 29, 2011

INDIANAPOLIS (AP) – Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said they have resubmitted to the Food and Drug Administration their application for a longer-lasting version of the diabetes treatment Byetta, and they expect the review to take up to six months.

The companies received European approval last month for the drug, labeled Bydureon, which is designed to be taken once a week. It is currently available in the United Kingdom.

Byetta, or exenatide, is taken twice a day and has been on the market for several years. Lilly, based in Indianapolis, and Amylin, headquartered in San Diego, are developing Bydureon along with Alkermes Inc. of Waltham, Mass. Alkermes created the technology that gradually releases the drug over the course of a week.

Last fall, the FDA declined to approve Bydureon and asked the companies to run a thorough study that evaluated effects of bigger doses of Bydureon on patient heart rates.

The companies said their reply contained results from the requested study, updated safety information and results from a study comparing Bydureon to Byetta.

In March, the companies said Bydureon proved inferior to Novo Nordisk’s Victoza according to initial results from a late-stage study. They said Bydureon reduced average blood sugar levels in type 2 diabetes patients by a smaller amount from a baseline measurement than Victoza. The study compared Bydureon with a maximum approved dose of 1.8 milligrams of Victoza administered daily.

Date: July 28, 2011
Source: Associated Press


Filed Under: Drug Discovery

 

Related Articles Read More >

FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

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.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 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 Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE