The US Food and Drug Administration (FDA) has rebuked Biogen Idec Inc. (Nasdaq: BIIB) for what it calls “misleading statements” on promotional web pages for the company’s multiple sclerosis treatment, Avonex. The FDA ordered Biogen to "immediately cease the dissemination of violative promotional materials for Avonex."
In a letter to Biogen, the FDA said that the web pages “overstate the efficacy of Avonex, omit material information, and present unsubstantiated superiority claims for the drug." The FDA says that the misleading information includes a chart that compares the efficacy of Avonex to several of its competitors, including Rebif, made by Serono and Pfizer Inc. (NYSE: PFE; LSE: PFZ), Copaxone, made Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), Betaseron, made by Bayer AG (DAX: BAYN), and its generic version, Extavia.
The chart only included select criteria that favored Avonex. "The totality of this presentation misleadingly implies that Avonex is superior to Copaxone, Rebif, Betaseron, and Extavia solely based on the select attributes presented. The chart shows that Avonex was approved in 1996, slows physical disability, reduces flare-ups, works after the first attack, is associated with fewer doses per year, and is available as an intramuscular injection in a prefilled syringe. The chart also presents information about these attributes for Copaxone, Rebif, Betaseron and Extavia. We note that the information included in the chart is consistent with the PI for each drug product. However, by failing to present information about other attributes associated with these products, the webpage misleadingly implies that Avonex is superior to the other drugs."
The FDA states that the web page fails to warn of the hazards of Avonex. "This presentation misleadingly overstates the efficacy of Avonex by implying that the drug will enable 80% of patients with relapsing forms of multiple sclerosis to stay active and able for 10 years, when this has not been demonstrated by substantial evidence or substantial clinical experience… Specifically the clinical studies section of the product label states, 'Safety and efficacy of treatment with Avonex beyond 3 years is not known.'"
The FDA concludes, "The FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Avonex is safer, more effective, or otherwise superior to Copaxone, Rebif, Betaseron or Extavia. If you have data to support such claims, please submit them to FDA for review."
Avonex had $2.7 billion revenue and Copaxone had $3.57 billion revenue in 2011.
Biogen spokeswoman Kate Niazi-Sai said the company was working with the FDA to resolve the matter according to the time frame the regulatory agency has set out.
Teva's share price rose 0.5% in morning trading on the TASE to NIS 161.40, after 0.4% on Nasdaq yesterday to $43.21, giving a market cap of $40.7 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on March 22, 2012
© Copyright of Globes Publisher Itonut (1983) Ltd. 2012