Biogen files to bring Tysabri back to market
Biogen files to bring Tysabri back to market
By Jeffrey Krasner, Globe Staff | September 27, 2005
Biogen Idec Inc. said it has submitted an application to the US Food and Drug Administration seeking a revised license so it can put its multiple sclerosis drug Tysabri back on the market.
The Cambridge company said the application contained the results of its extensive safety review of Tysabri use by multiple sclerosis patients and trial participants, and ''nearly complete" results of its safety review of participants in trials for Crohn's disease and rheumatoid arthritis.
''We are grateful to the MS community for their patience and support over the last several months while we've conducted an extensive safety evaluation of Tysabri in collaboration with leading experts," said Burt Adelman, Biogen Idec's executive vice president of development, in a statement. ''We look forward to working with regulatory authorities during the review process, and ultimately, we hope to provide Tysabri to people living with MS."
A Biogen Idec spokeswoman said the company asked the FDA for accelerated review of the application. If granted, the FDA could respond to the application within six months, rather than 10. A decision on the accelerated review request is expected within 30 days.
Biogen Idec and its partner Elan Pharmaceuticals of Ireland in February voluntarily pulled Tysabri off the market and discontinued clinical trials. One patient taking the drug had died of a rare brain disease and a second was suspected of having contracted it. That patient recovered. A third case of the disease was discovered among patients who had taken the drug for Crohn's disease, an intestinal ailment.
Since then, Biogen Idec has been scouring the records of patients who took Tysabri in clinical trials and during its time on the market. It said it hasn't found any other cases of the brain disease.
Analysts believe Biogen Idec will seek to restart Tysabri sales with a new warning label. Amy Brockelman, a company spokeswoman, declined to comment on the proposed labeling language. ''It's premature to comment on the specifics of the label while we're in discussions with regulatory authorities," she said.
Biogen Idec also filed similar safety review data with the European Medicines Agency. Tysabri hasn't been approved for sale in Europe and the new information will be added to the company's pending application.
© Copyright 2005 The New York Times Company
By Jeffrey Krasner, Globe Staff | September 27, 2005
Biogen Idec Inc. said it has submitted an application to the US Food and Drug Administration seeking a revised license so it can put its multiple sclerosis drug Tysabri back on the market.
The Cambridge company said the application contained the results of its extensive safety review of Tysabri use by multiple sclerosis patients and trial participants, and ''nearly complete" results of its safety review of participants in trials for Crohn's disease and rheumatoid arthritis.
''We are grateful to the MS community for their patience and support over the last several months while we've conducted an extensive safety evaluation of Tysabri in collaboration with leading experts," said Burt Adelman, Biogen Idec's executive vice president of development, in a statement. ''We look forward to working with regulatory authorities during the review process, and ultimately, we hope to provide Tysabri to people living with MS."
A Biogen Idec spokeswoman said the company asked the FDA for accelerated review of the application. If granted, the FDA could respond to the application within six months, rather than 10. A decision on the accelerated review request is expected within 30 days.
Biogen Idec and its partner Elan Pharmaceuticals of Ireland in February voluntarily pulled Tysabri off the market and discontinued clinical trials. One patient taking the drug had died of a rare brain disease and a second was suspected of having contracted it. That patient recovered. A third case of the disease was discovered among patients who had taken the drug for Crohn's disease, an intestinal ailment.
Since then, Biogen Idec has been scouring the records of patients who took Tysabri in clinical trials and during its time on the market. It said it hasn't found any other cases of the brain disease.
Analysts believe Biogen Idec will seek to restart Tysabri sales with a new warning label. Amy Brockelman, a company spokeswoman, declined to comment on the proposed labeling language. ''It's premature to comment on the specifics of the label while we're in discussions with regulatory authorities," she said.
Biogen Idec also filed similar safety review data with the European Medicines Agency. Tysabri hasn't been approved for sale in Europe and the new information will be added to the company's pending application.
© Copyright 2005 The New York Times Company
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