Posts tagged ‘BYDUREON’

BYDUREON rejection

Nobody saw this one coming!  Nobody but the FDA that is.  Cardiovascular safety has been a very hot item with the FDA for a very long time.  The rejection of the BYDUREON NDA certainly sends a message to the rest of the industry on two points.  First, the cardiovascular profile has still got  to be extremely clean. Nothing new there.  We’ve seen several high profile drugs rejected this year because of CV safety issues.   Second, if the product is an extended release, the pharmacokinetics have got to match the dosing regimen.  Nothing new there either.  Combine these two points such that you get some cardiovascular safety issues that might be associated with drug accumulation and it spells rejection.