The information found here is in this weeks edition of the MSFYi newsletter provided by the MS Foundation
The first oral treatment indicated for relapsing forms of MS, Gilenya™ (fingolimod), has been approved by the US Food and Drug Administration (FDA). Gilenya, previously referred to as compound "FTY720", will be available in US pharmacies in the coming weeks, according to the announcement made by Novartis. Novartis has also said it will offer educational support and reimbursement services for people who will be taking Gilenya. For more information, visit www.Gilenya.com or call 1-877-408-4974.
Gilenya will be available as a first-line treatment, which means that there are no recommendations in the approved labeling for people to try other MS therapies before taking Gilenya. Positive results from two large-scale phase III clinical trials have been published showing that fingolimod significantly reduced MS relapse rates and reduced disease activity as measured by MRI.
The most common adverse reactions listed in Gilenya’s prescribing information are headache, flu, diarrhea, back pain, liver enzyme elevations, and cough.
Other potential serious risks are described. The long-term safety of Gilenya is unknown at this time. Other phase III clinical trials of Gilenya, including one involving people with primary progressive MS, are still underway, as are extension studies involving those who have completed trials. These and other post-marketing studies should provide additional data on the safety and efficacy of Gilenya.
Other potential serious risks are described. The long-term safety of Gilenya is unknown at this time. Other phase III clinical trials of Gilenya, including one involving people with primary progressive MS, are still underway, as are extension studies involving those who have completed trials. These and other post-marketing studies should provide additional data on the safety and efficacy of Gilenya.
Talk to your doctor about whether Gilenya is right for you. The effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors will play a part in that decision.
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Disclaimer: 'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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1 comments:
And apparently, whether you can afford it without Medicare... $4,000
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