This article originally posted 28 July, 2011 and appeared in Medication, Issue 584
Lilly Resubmits Bydureon to FDA
Bydureon could be available by Feb or March of 2012 or even sooner. Because Bydureon is the same drug as Byetta (which has been in the market for over 5 years and basically is the same drug) except that Bydureon only needs to be injected once a week instead of twice a day, there is a good likelihood that it will be approved with the new information that is being submitted....
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The best news to come out of last week's earnings report for Amylin is they are going to resubmit their application to the FDA as a Class II resubmission. This submission will mean that there would be a 6 month review period. If all goes well, we would see Bydureon in the market sometime in the first quarter of 2012.
With the picture for Bydureon becoming clearer, attention is now focused on the status of the Amylin Lilly legal battle about Lilly promoting another company's DPP-4 inhibitor drug, Tradjenta. While the case is ongoing and the two sides continue to battle in court, what everyone wants to know is how this legal squabble will impact the launch of Bydureon. Can the two sides set aside their differences, or at least work together well enough to insure that Bydureon gets off to a good start?
Lilly's and Amylin's once a week injection drug, Bydureon has the capability of becoming a block buster drug for those with Type 2 diabetes.
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