For Patients’ Good or Company Rival: The Petition of TEVA to FDA on Biogen Idec
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Several days ago, Teva Pharmaceutical Industries Ltd, which has the market-leading multiple sclerosis drug Copaxone, handed a petition to the U.S. FDA. In the petition, Teva asked FDA to, if possible, delay the market entry of Biogen Idec Inc.’s new MS 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. The company said it is on behalf of 300,000 relapsing remitting MS patients’ profit and safety.
According to Teva, kidney changes have be observed after repeated administration of BG-12 in mice, rats, dogs and monkeys. As a result, Teva concluded the potential risk might also be applicable to human.
Regarding on this “accuse”, Biogen made response at the J.P. Morgan Healthcare Conference earlier this week, which said Biogen is "confident" in BG-12's safety data, the incidence of kidney problems was similar between patients taking BG-12 and those taking a placebo, the spokesman 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.
Article Link: For Patients’ Good or Company Rival: The Petition of TEVA to FDA on Biogen Idec
Tags: FDA, TEVA, Biogen Idec, Multiple Sclerosis, Drug Safety