Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA's "Complete Response" Letter For Byetta LAR Isn't Too Onerous, Amylin Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Analysts still expect an approval and launch by year end of long-acting exenatide, now branded as Bydureon.

You may also be interested in...

Bydureon Approval Provides Lesson In Clinical Data Requirements For Biosimilars

Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.

With Bydureon’s U.S. Approval, Amylin Extends Exenatide Franchise

Twice delayed by “complete response” letters, the drug’s approval gives Amylin a once-weekly GLP-1 analog, the longest-acting drug in its class.

Amylin Plans Cardiac Safety Study By The Book After Bydureon Rejection

There’s more than meets the eye to the story of the seemingly surprising “complete response” letter for Amylin’s ultra-high-profile once-weekly diabetes injectable Bydureon.

Related Content


Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts