Food and Drug Administration call for more information on Amylin diabetes drug

Sat, 20 Mar 2010
According to diabetes news today, Amylin Pharmaceuticals Inc revealed that they had received a request from the Food and Drug Administration for information about manufacturing and a risk mitigation plan for their proposed once a week diabetes treatment .

Amylin have partnered with Eli Lilly and Company as well as Alkermes Inc. The FDA has requested a focus on product labelling for the new diabetes drug Bydureon (trade name for exenatide.) The FDA also require risk mitigation data and manufacturing information, which Amylin will now work to supply.

Exenatide is a once-per-week version of injectable diabetes treatment Byetta, currently being taken twice per day by thousands of diabetes patients in the UK. The drug will be one of the first in the GLP-1 class, to accompany the Novo Nordisk drug Victoza .
Leave a Comment
Login via Facebook, Yahoo! and Hotmail
or
Have your full say in the Diabetes Forum
Your comments may be moderated. Please report any spam, illegal, offensive or libellous posts.