By Peter Loftus
Teva Pharmaceutical Industries Ltd. (>> Teva Pharmaceutical Industries Ltd (ADR)), which sells the blockbuster multiple-sclerosis drug Copaxone, has asked the U.S. Food and Drug Administration not to approve any new MS drugs until their safety risks have been evaluated by outside advisers.
Teva's petition is aimed at Biogen Idec Inc. (>> Biogen Idec Inc.), which expects an FDA decision by late March on Biogen's application to market a new MS treatment, known as BG-12, an orally administered pill that analysts expect will be a formidable competitor to the injected Copaxone.
In a Dec. 31 citizen petition to the FDA, Teva asked the agency not to approve any new MS drugs until the agency refers them to an advisory committee for evaluation. Advisory committees sometimes review new drug applications to provide guidance to the agency.
Teva said it was important for the agency to hear outside advisers' evaluations of any safety risks, in light of risks that have emerged after MS treatments were approved in recent years, including Biogen's own Tysabri MS treatment. Tysabri was removed from the market soon after its 2004 introduction after some recipients experienced a serious brain infection, and reintroduced in 2006 with a patient-monitoring plan.
Teva said in its petition that BG-12 "may be associated with other serious safety risks" including the potential risk for kidney-related problems.
Teva cited a publicly accessible website containing animal toxicology data suggesting that kidney changes were seen in animals after they received BG-12's active ingredient, dimethyl fumarate, in studies. The website stated that the relevance of these findings to humans isn't known, according to the Teva petition.
Biogen spokeswoman Kate Niazi-Sai said the company is confident in the clinical data supporting BG-12's safety and efficacy, and the regulatory review appears to be on track.
Results of a late-stage clinical trial of BG-12 published last year in the New England Journal of Medicine showed the incidence of kidney-related adverse events was similar between those receiving BG-12 and those on a placebo. There were no cases of kidney failure classified by researchers as serious adverse events, according to the article.
RBC Capital Markets analyst Shibani Malhotra, who reported the Teva citizen petition in a research note earlier Wednesday, said it may not pose a big obstacle for BG-12's approval because a similar drug has been available as a psoriasis treatment in Europe, and serious safety issues haven't emerged.
RBC analyst Michael Yee said he still expects the FDA to approve BG-12 by the targeted action date in late March.
On Monday at the J.P. Morgan Healthcare conference in San Francisco, Biogen Chief Executive George Scangos defended the experimental MS pill. He acknowledged there has been some chatter about BG-12 safety, but chalked this up to competitors marketing against the product.
"We're very confident in the safety," he said. "I kind of take it as a compliment that the competition is worried about BG-12."
Teva spokeswoman Denise Bradley said the petition was intended to bring to light important points "to protect the safety of patients." Teva wants to ensure "that appropriate safeguards are implemented to maintain an acceptable risk-benefit profile" for any new MS drug, she said.
FDA spokeswoman Sandy Walsh said the agency will review the petition.
--Jon Kamp contributed to this article.
-Write to Peter Loftus at [email protected]
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