Entereg gets hospitalized

Entereg alvimopan from Adolor Corp. and GlaxoSmithKline plc, approved last week to treat postoperative ileus following bowel resection surgery, will be the first new molecular entity to reach the market with a risk evaluation and mitigation strategy, the risk management toolkit created by the FDA Amendments Act of 2007.

Senior FDA officials are acutely aware that the first cohort of REMS will set precedents. Extra scrutiny, from both drug safety officials and FDA's lawyers, slowed the Entereg review and was partly responsible for the agency missing the Feb. 10 PDUFA deadline by over three months, according to Adolor and FDA...