| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers B > Headlines for Biogen Idec Inc. > News item |
No new PML cases in patients taking Tysabri, Elan, Biogen say
By E. Janene Geiss
Philadelphia, Oct. 17 - Elan Corp. plc and Biogen Idec Inc. announced Monday that findings from safety evaluations of the drug Tysabri in patients with Crohn's disease and rheumatoid arthritis resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML).
Company officials began a safety evaluation after three confirmed cases of PML were reported. Two of those cases were fatal, the release said. That safety evaluation is now complete, the release said.
Previously announced findings from safety evaluations of Tysabri in patients with multiple sclerosis also resulted in no new cases, the release said.
On Sept. 26, the companies said they submitted a supplemental Biologics License Application for Tysabri to the U.S. Food and Drug Administration for the treatment of multiple sclerosis. The companies also recently submitted a similar data package to the European Medicines Agency, the release said.
On Feb. 28, the companies voluntarily suspended Tysabri from the U.S. market and all ongoing trials after patients reported PML, a rare and potentially fatal, demyelinating disease of the central nervous system, according to a news release.
More than 1,500 Crohn's and arthritis patients from clinical trials were eligible for the safety evaluation. A total of 88% of these patients participated, officials said. Ninety-eight percent of participating patients had a neurological exam and an MRI exam, officials said.
Dublin, Ireland-based Elan Corp. is a neuroscience-based biotechnology company.
Cambridge, Mass.-based Biogen Idec develops, manufactures and commercializes therapies in oncology, neurology and immunology.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.