(Reuters) - Teva Pharmaceutical Industries Ltd, which makes the market-leading multiple sclerosis drug Copaxone, has filed a petition with the U.S. Food and Drug Administration that could, if granted, delay entry to the market of a rival drug developed by Biogen Idec Inc.
Teva’s petition asks that the FDA not approve any new multiple sclerosis drug until its safety has been evaluated by a panel of outside advisors, and said it had uncovered “troubling information” on a publicly accessible website about the safety of Biogen’s drug, BG-12.
Israel-based Teva said the information showed 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.”
Biogen spokeswoman Kate Niazi-Sai, echoing comments made by company chief executive, George Scangos, at the J.P. Morgan Healthcare Conference earlier this week, said the company is “confident” in BG-12’s safety data.
Niazi-Sai said the incidence of kidney problems was similar between patients taking BG-12 and those taking a placebo, she said. A late-stage clinical trial showed that 21 percent of patients taking the placebo experienced kidney problems, compared with 22 percent of patients taking BG-12 twice a day and 25 percent of patients taking BG-12 three times a day.
Teva asked the FDA not to approve any new MS drug unless or until it has convened a panel of outside advisors and listened to the panel’s recommendations. And it said its motives were to protect patients.
“Teva filed the petition, on behalf of the more than 300,000 patients with relapsing remitting multiple sclerosis in the U.S.,” Denise Bradley, a spokeswoman for Teva, said in an emailed statement. She said the company wants to “ensure that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile.”
So far the agency has not scheduled such a meeting for BG-12, though it could do so at any time. An advisory committee meeting would delay BG-12’s entry to the market.
The FDA is scheduled to rule on whether to approve BG-12 by the end of March, three months later than the original decision date. Biogen has said the agency did not require additional information, just more time to review application.
Brian Abrahams, an analyst at Wells Fargo Securities, said he doubts Teva’s petition will cause the FDA to delay BG-12’s approval, “though one cannot rule out the possibility of a minor process-related delay as FDA necessarily evaluates/responds” to the petition.
Reporting by Toni Clarke in Boston; Additional reporting by Bill Berkrot in New York; Editing by Tim Dobbyn