FDA Needs More Time To Review GSK/Adolor’s Entereg

Adolor tells investors that FDA will not act on the postoperative ileus treatment in time to meet the May 10 PDUFA date.

FDA will not meet the scheduled May 10 action date for GlaxoSmithKline/Adolor's Entereg (alvimopan) for postoperative ileus, Adolor alerted the investment community May 9.

"The FDA did not provide a specific date, but informed the company that it expects to issue the action letter shortly," Adolor said. The agency already pushed back the user fee date for Entereg by two months to have more time to review a new risk management program for the drug that was submitted in February (¹ (Also see "Entereg User Fee Date Pushed Back To May" - Pink Sheet, 8 Feb, 2008.)).

The firms have been seeking marketing approval for Entereg to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery since submitting an NDA in 2004. The application has so far been the subject of two "approvable" letters, the second of which cited concerns with an increased risk of myocardial infarction, seen in a long-term study in patients with opioid-induced bowel dysfunction.

During a meeting of FDA's Gastrointestinal Drugs Advisory Committee in January, the panel found that the benefits of Entereg outweigh cardiovascular risks for POI, but maintained that the risk management plan for the drug - which focused on limiting its use to hospital patients - was inadequate (² (Also see "GSK/Adolor's Entereg Eligible For Approval, But Lacks Proper Risk Management Plan, Advisory Panel Says" - Pink Sheet, 23 Jan, 2008.)

Drugs with risk management provisions also are subject to FDA's new Risk Evaluation & Mitigation Strategy requirements, part of the FDA Amendments Act signed into law in September 2007, which took effect March 25. UCB's tumor necrosis factor inhibitor Cimzia (certolizumab), approved for Crohn's disease in April, was the first new molecular entity to be approved with a REMS.

-Jessica Merrill ([email protected])