Teva questions safety of rival MS drug BG-12

Source: Reuters Area: News Teva Pharmaceutical Industries Ltd, which markets glatiramer (Copaxone) has filed a petition with the FDA that could, if granted, delay entry to the market of a rival drug (dimethyl fumarate/ BG-12) developed by Biogen Idec Inc.   Teva's petition asks the FDA not to approve any new multiple sclerosis drug until its safety has been evaluated by a panel of outside advisors, and said it had uncovered information on a publicly accessible website about the safety of Biogen's drug; namely that kidney changes were observed after repeated administration of BG-12 in mice, rats, dogs and monkeys. The company suggested that as a result, "there is a substantial probability the risk is applicable to humans as well." A spokeswoman for Teva said that the company wants to "ensure that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile."   A Biogen spokeswoman said the company is "confident" in BG-12's safety data, adding that the incidence of ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news