Teva wants FDA panels for new MS treatments

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) sent a Citizen's Petition to FDA asking the agency to "refrain from approving" any multiple sclerosis drug unless the product has been reviewed by the Peripheral and Central Nervous System Advisory Committee. Teva, which markets MS drug Copaxone glatiramer acetate, said that "given the recent history of emerging, serious safety issues" for Tysabri natalizumab from Elan Corp. plc (NYSE:ELN) and Biogen Idec Inc. (NASDAQ:BIIB) and Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN), FDA should hold advisory meetings before approving any new MS treatments. The petition failed to mention that the agency held advisory committee meetings prior to approval of both Tysabri and Gilenya. FDA, which acknowledged receipt of the Citizen's Petition, is not required to respond to or take any other action on the petition.

In the petition, Teva also cited "potential risks for renal adverse events" with BG-12 from Biogen Idec. The oral dimethyl fumarate that activates the NF-E2-related factor 2 (Nrf2) pathway is under review for MS with a PDUFA date in late March. Teva said BG-12 data that were temporarily available on a publicly accessible website show kidney changes after repeated oral administration of BG-12 in animals. Teva also said the website was "unlawful, pre-approval promotion of an unapproved drug." ...