Cymbalta duloxetine regulatory update

FDA's Anesthetic and Life Support Drugs Advisory Committee voted 8-6 in favor of approving an sNDA to expand the pain indications for Eli Lilly's Cymbalta duloxetine. The panel voted 8-5 with one abstention that Lilly had shown the compound to be efficacious to manage chronic lower back pain (CLBP), but 9-4 with one abstention that the company had not done so for the treatment of chronic pain due to osteoarthritis (OA). The panel also voted 9-4 with one abstention that the compound's safety profile and overall risk-benefit profile warranted label expansion.

Lilly is seeking to expand the drug's label to include chronic pain. In a memo dated July 26, FDA Division of Anesthesia and Analgesia Products Director Bob Rappaport said that the "mix and number of patient populations studied in the Cymbalta development program would be adequate to support this broadened indication." However, at Thursday's panel meeting, he said the division was changing its requirements and that Cymbalta's development program was no longer adequate to obtain that indication. Rappaport also said the agency is working on guidance for the development of chronic pain products. ...