Treatment Updates

New Data Support Early Interferon Treatment for Multiple Sclerosis

Nov 12, 2009
In a study of 2,570 people with MS, early treatment with interferon therapy was associated with a significant reduction in the risk of MS progression. Maria Trojano, MD (University of Bari, Italy) and colleagues from 14 other Italian centers report their findings in Annals of Neurology. (2009 May 28;66(4):513-520)

Update on Tysabri and PML: Company Releases Details of Cases and Risks

Oct 29, 2009
According to information released yesterday by Biogen Idec, there have been 24 confirmed cases of PML among people who have used Tysabri after it became available for prescription in July 2006. Some details about the 24 cases are provided.

European Drug Agency to Weigh Risks/Benefits of Tysabri -- cites 23 cases of PML

Oct 23, 2009
Today the EMEA, the European equivalent of the U.S. FDA, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri in light of 23 confirmed cases of PML that it says have occurred since the drug has been on the market.

PreCISe Study Results – Showing Benefit of Copaxone® in People at High Risk for MS – Published

Oct 07, 2009
Results of the PreCISe Study – which showed that early treatment with Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries) delayed the development of definite multiple sclerosis – have now been published. Dr. Giancarlo Comi (Scientific Institute San Raffaele, Milan) and colleagues presented results of this study at the Annual Meeting of the American Academy of Neurology in 2008, and based on these results, the U.S. Food and Drug Administration (FDA) extended the labeling of Copaxone to include people with MS who have experienced a first clinical episode and have MRI features consistent with MS. The team’s report has now been published in the Lancet (published online October 7, 2009).

Update on Tysabri and PML

Sep 18, 2009
According to the FDA, there have been 13 confirmed cases of PML, a viral infection of the brain that usually leads to death or severe disability, among people who have used Tysabri after it became available for prescription in July 2006. The latest post-marketing safety warnings provided by the FDA on Tysabri can be found at this link: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm

New Brand of Interferon Beta for Treating MS Approved by FDA

Aug 18, 2009
Novartis Pharmaceuticals Corporation announced that the FDA has approved the marketing of Extavia®, its own brand of interferon beta-1b, the same disease-modifying therapy that has been marketed as Betaseron® (Bayer Schering Pharma) since it was approved in 1993 to reduce the frequency of MS exacerbations. The release of the same product under a new brand name was made possible through an agreement between Novartis and Bayer Schering.

Guidelines for Administration of Human Papillomavirus (HPV) Vaccine (Gardasil®) to Multiple Sclerosis Patients - UPDATED

Aug 13, 2009
Gardasil® (Merck) is available as a prophylactic vaccine, designed to prevent the following conditions in girls and women 9 to 26 years of age: HPV 6, 11, 16 and /or 18-related cervical cancer, cervical dysplasias, vulvar and vaginal dysplasias, condyloma acuminata.

FDA Extends Copaxone Labeling To Include Those Experiencing First Attack and Having MRI Scan Suggestive Of MS

Mar 05, 2009
According to the drug’s sponsor, the U.S. Food and Drug Administration (FDA) has extended the labeling of Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries) to include people with MS who have experienced a first clinical episode and have MRI features consistent with MS. The FDA based its decision on the findings of the “PreCISe” study, funded by Teva.

Tysabri Update: New Published Papers Explore its Benefits, and New Case of PML Reported

Feb 10, 2009
Two newly published papers explore aspects of how Tysabri® (natalizumab, Biogen Idec, Inc and Elan Pharmaceuticals) impacts relapsing multiple sclerosis.