Category: Latest News

On April 20, 2012, Novartis announced changes to the prescribing information for Gilenya® (fingolimod) in the treatment of relapsing forms of multiple sclerosis (MS). This new prescribing information is applicable only to individuals who have not been given a first dose of Gilenya or for those who have stopped and will be restarting the drug. These changes do not affect any guidelines for individuals who are currently taking Gilenya.

Novartis released a safety information update on April 13, 2012 stating that an individual with MS who was taking Gilenya® (fingolimod) was diagnosed with progressive multifocal leukoencephalopathy (PML). This infection of the brain has been associated with another treatment for MS, Tysabri® (natalizumab). Depending on the risk factors discussed below, a small number of MS patients may develop PML either while taking Tysabri or up to three months after discontinuing this drug.

Biogen Idec announced last week that the United States Food and Drug Administration (FDA) has approved both a new device (the Avonex Pen) as well as a new dosing regimen for Avonex (interferon beta-1a). These two approvals are aimed at assisting patients who are either taking Avonex presently, or who are just starting Avonex, for the treatment of relapsing forms of multiple sclerosis (MS).

Biogen Idec announced last week that they have submitted an application to the United States Food and Drug Administration (FDA) for approval of BG-12 (dimethyl fumarate), an experimental oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company plans to also submit an application for the same drug to the European Medicines Agency (EMA) shortly. Biogen Idec expects to hear back from these two agencies within a few months regarding the status and potential approval of BG-12.

The Multiple Sclerosis Association of America (MSAA) is pleased to recognize March as MS Awareness Month. During the month of March, MSAA will be highlighting various programs designed to expand knowledge, understanding, and support of individuals whose lives are affected by multiple sclerosis (MS).

On January 20, 2012, the United States Food and Drug Administration (FDA) announced that three factors are now identified with increasing the risk of Progressive Multifocal Leukoencephalopathy (PML) for individuals with multiple sclerosis (MS) being treated with Tysabri® (natalizumab). PML is a potentially fatal brain infection with the JC virus (JCV), in people with weakened immune systems. The FDA has approved a labeling change, which adds the results of a newly approved test for the presence of anti-JCV antibodies, to the two previously listed risk factors.

The Multiple Sclerosis Association of America (MSAA) is pleased to announce My MS Manager ™, MSAA’s mobile phone application, has been honored by the Web Health Awards | MOBILE with a Merit Award in the category of Mobile Application: Chronic Disease Management; Small Mobile Device in the Association/Professional Society/Non-Profit division.

The European Medicines Agency (EMA) announced today that it has started a review of Gilenya (fingolimod) in response to reports of potential heart issues associated with the first dose of this drug.

The United States Food and Drug Administration (FDA) has notified the public that a packaging problem may have occurred with eight narcotic-type drugs (such as Opana®, Percocet®, and Endocet®), where a stray pill may have gone into another’s packaging.

Novartis Pharmaceuticals Corporation has informed the Multiple Sclerosis Association of America (MSAA) that a patient with multiple sclerosis (MS), who had been given one dose of Gilenya® (fingolimod), died on the following day. The individual’s death occurred on November 23, 2011.