Treatment Updates

FDA Updates Tysabri Label to Include Lab Test that Helps Identify Person’s Risk of Developing PML

Jan 23, 2012
The U.S. FDA has approved a change to the prescription label for Tysabri to show that a lab test that detects antibodies to the JC virus can help determine a person’s risk of developing PML, a severe brain infection. PML has emerged in some people who have taken Tysabri. The lab test should enhance the ability to weigh risks and benefits of this therapy.

European Medicines Agency Commences Safety Review of Gilenya

Jan 20, 2012
The European Medicines Agency has started a review of the oral medication Gilenya (fingolimod, Novartis) after reports issued on January 20 that there have been 11 deaths among patients who received treatment. Our sympathies go out to the families of all of these individuals. As more information becomes available, we will release it as soon as possible to the MS community.

Study Shows Potential of Lab Test to Detect Virus Which Causes PML in People with MS – ongoing study may help identify risk for PML in people treated with natalizumab

Dec 22, 2011
Biogen Idec researchers have published results on a blood test that detects antibodies to the JC virus, the virus responsible for PML. This paper reports that in an ongoing study of over 1,000 people being treated or considering treatment with Tysabri, 56% had evidence of JC virus antibodies. The presence of antibodies indicates that a person has at some point been infected by or exposed to the virus. Ultimately the study may show whether detection of antibodies to JC virus can help guide treatment decisions.

Possible Safety Issue Being Investigated with Novartis Pill Gilenya

Dec 12, 2011
Our sympathies go out to the family of an individual who recently died within 24 hours of receiving a first dose of the oral medication Gilenya. Novartis has confirmed this event and has reported it to the FDA. Until more information is available about the circumstances of this individual’s death, it is impossible to know what role Gilenya may have played in it.

Multiple Sclerosis Emerging Therapies Collaborative - UPDATE

Nov 14, 2011
We are proud to announce the launch of the Multiple Sclerosis Emerging Therapies Collaborative. The Collaborative – which includes the members of the MS Coalition, the American Academy of Neurology, and the VA Multiple Sclerosis Centers of Excellence East and West – has as its mission:

FDA Approves Botox® for Treating Urinary Incontinence in MS and other Neurologic Conditions

Aug 30, 2011
A new use for Botox® (onabotulinumtoxin A, Allergan, Inc.) was approved by the FDA, providing an additional treatment option for people with MS or other neurologic disorders who experience urinary incontinence.

Information from Medtronic about possible battery issues in Synchromed® drug pumps

Aug 15, 2011
In July, Medtronic provided physicians with new information about possible reduced battery performance in a small percentage of the SynchroMed® drug pumps used to deliver intrathecal baclofen, a medication used to treat severe spasticity. A battery with reduced performance may need to be replaced sooner than expected. In addition, the reduced performance may cause the drug flow rate to be reset to a very low level. In the event of reduced battery performance, a person would experience a significant increase in spasticity or and perhaps some withdrawal symptoms as the supply of medication is decreased. Medtronic is NOT recommending pump replacement because the risk of this change in battery performance is very low, and the surgery poses its own risks. The pump’s alarm system will sound if there is a problem. Read here for more information.

FDA issues warning about medications containing oxybutynin

Jul 15, 2011
Some of medications (Ditropan®, Ditropan XL®, Gelnique® gel, Oxytrol® transdermal patch) used to treat urinary problems in people with MS contain oxybutynin. The FDA has added a warning to the labeling of these medications stating that angioedema (a swelling similar to hives that occurs under the skin) of the face, lips, tongue and/or larynx has been reported with oxybutynin taken orally.

UPDATE on Tysabri and PML

Apr 11, 2011
According to a safety announcement released by the FDA, as of January 4, 2012 there have been 201 confirmed cases of progressive multifocal leukoencephalopathy (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. In January 2012, the prescribing information was updated to include new information about the incidence and risk factors of PML among people with MS taking Tysabri.

FDA Sends Letter Stating that the Application to Market Oral Cladribine for MS is Not Ready for Approval -- Outlines Need for Additional Data

Mar 02, 2011
The FDA has issued a “Complete Response Letter” to EMD Serono indicating that the company’s application to market oral Cladribine to treat relapsing forms of MS is not ready for approval in its current form, and outlining requirements for additional information. At this point it is difficult to predict when the company might address the agency’s requirements. Read more details here.