Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has filed a citizens petition with the US Food and Drug Administration (FDA) not to approve any new drugs for multiple sclerosis until their safety risks have been evaluated by outside advisers, the US media reports. Teva's multiple sclerosis drug, Copaxone, has billions of dollars in annual sales.
"Dow Jones News Wire" reports that Teva's petition targets Biogen Idec Inc. (Nasdaq: BIIB), which expects an FDA decision by late March on Biogen's application to market a new multiple sclerosis treatment, known as BG-12, an orally administered pill that analysts expect will be a formidable competitor to the injected Copaxone.
In the petition, filed on December 31, 2012, Teva asked the FDA not to approve any new multiple sclerosis drugs until the FDA 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 FDA to consult outside advisers' evaluations of any safety dangers, in light of risks that have emerged after multiple sclerosis treatments were approved in recent years, including Biogen's own Tysabri multiple sclerosis treatment. Tysabri was taken off the market shortly after its 2004 launch after some patients 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 is quoted by the US media as saying that the company was confident in the clinical data supporting BG-12's safety and efficacy, and the regulatory review appears to be on track. It adds that 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, and that rhere were no cases of kidney failure classified by researchers as serious adverse events.
"Dow Jones News Wire" quotes Teva spokeswoman Denise Bradley as saying that the petition was intended to bring to light important points "to protect the safety of patients," and that Teva wanted to ensure "that appropriate safeguards are implemented to maintain an acceptable risk- benefit profile" for any new multiple sclerosis drug.
FDA spokeswoman Sandy Walsh said the agency would review the petition.
Published by Globes [online], Israel business news - www.globes-online.com - on January 10, 2013
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