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

UsernamePublicRestriction

Amylin Byetta Antibodies Could Be Root Of Response Variability In Pivotals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Patients showing a poor response to Lilly/Amylin’s type 2 diabetes treatment Byetta have high numbers of antibodies to the incretin mimetic, FDA review documents suggest.

You may also be interested in...



Byetta sNDA for TZD combo use

Lilly and Amylin submit an sNDA for the use of incretin mimetic Byetta (exenatide) as add-on therapy to thiazolidinediones (TZDs) in people with type 2 diabetes, the firms announce March 1. The filing comes ahead of schedule: Amylin previously had predicted a mid-2006 filing of the supplement (1Pharmaceutical Approvals Monthly January 2006, p. 28). In the pivotal trial supporting the sNDA, 62% of Byetta-treated patients with baseline A1C over 7% reduced their A1C to 7% or less compared to 16% of similar placebo patients...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals

Product

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003131

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

Cancel