The long and short of Entereg

FDA's decision on the NDA for Entereg alvimopan due early next month could provide yet another indicator of the agency's risk tolerance. The decision also will provide insights into the risk evaluation and mitigation strategy (REMs) process that will come into effect later this year.

In making a decision, FDA's task will be to weigh the efficacy of Entereg in hastening the resumption of gastrointestinal function following bowel resection surgery, a benefit that does not save or extend lives, against an ambiguous signal of increased risk of serious and fatal cardiovascular events...