08.03.2006 20:17:00
|
FDA Advisory Committee Unanimously Recommends Reintroduction of TYSABRI(R) for the Treatment of Relapsing Forms of Multiple Sclerosis
The Committee's recommendation is advisory to the FDA, and theagency is not bound by this recommendation. The FDA has designatedTYSABRI for Priority Review, a status for products that are consideredto be significant therapeutic advancements over existing therapiesthat address an unmet medical need. Biogen Idec and Elan will continueto work closely with the FDA in the weeks ahead with the goal ofmaking TYSABRI available. Discussions with FDA will include, amongother things, finalizing the details of the TYSABRI risk managementplan. The companies anticipate action by the FDA by March 29, 2006.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurologyand immunology. As a global leader in the development, manufacturing,and commercialization of novel therapies, Biogen Idec transformsscientific discoveries into advances in human healthcare. For productlabeling, press releases and additional information about the company,please visit www.biogenidec.com.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnologycompany committed to making a difference in the lives of patients andtheir families by dedicating itself to bringing innovations in scienceto fill significant unmet medical needs that continue to exist aroundthe world. Elan shares trade on the New York, London and Dublin StockExchanges. For additional information about the company, please visitwww.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regardingthe potential and regulatory path forward of TYSABRI. The commercialpotential and regulatory path forward of TYSABRI are subject to anumber of risks and uncertainties. Factors which could cause actualresults to differ materially from the companies' current expectationsinclude the risk that we may unable to adequately address concerns orquestions raised by FDA or European regulatory authorities during theregulatory review process, that concerns may arise from additionaldata or analysis, or that the companies may encounter other unexpecteddelays or hurdles. There is also no assurance that the companies willbe able to resume marketing and sales of TYSABRI. Drug development andcommercialization involves a high degree of risk. For more detailedinformation on the risks and uncertainties associated with thecompanies' drug development and other activities, see the periodicreports that Biogen Idec and Elan have filed with the Securities andExchange Commission. The companies assume no obligation to update anyforward-looking statements, whether as a result of new information,future events or otherwise.
Wenn Sie mehr über das Thema Aktien erfahren wollen, finden Sie in unserem Ratgeber viele interessante Artikel dazu!
Jetzt informieren!