Teva Pharmaceuticals has filed a petition to the US Food and Drug Administration requesting it not to approve any new treatment of multiple sclerosis until its safety has been evaluated by a panel of experts, a plea that could delay the approval of Biogen‘s drug BG-12.
Israel-based Teva, which makes the world’s best-selling MS drug Copaxone, said it had uncovered troubling information about the safety and effectiveness of BG-12 capsules, also known as Panoplin.
The firm said the information, posted on a "publicly accessible website", contained animal toxicology data showing that kidney changes were observed after repeated oral administration of BG-12 in mice, rats, dogs and monkeys.
Although the website stated that the relevance of these findings to humans is not known, Teva suggested there "is a substantial probability the risk is applicable to humans as well."
The petition also makes reference to safety issues linked to MS drugs Tysabri (nataluzimab) developed by Biogen and Elan, and Novartis’ Gilenya (fingolimod), including progressive multifocal leukoencephalopathy (PML) and cardiac events.
Teva states that in light of this history it requests that the Commissioner of Food and Drugs refrain from approving any new drug for the treatment of MS until the FDA has referred the new drug to, and considered the recommendations of, the Peripheral and Central Nervous System Advisory Committee.