Before I get to that, however, I want to tell you all a little about my friend, Rhonda. She is a Life, Wellness and Career Coach! If you feel stuck, whether it be because of a job-related issue, a health-related issue, or just a life issue and you need someone to help you through, I would encourage you to contact Rhonda. Although she is equipped to help with a range of issues, I should mention (since this blog is about MS) that I met Rhonda through her work for the MS Society, so I know she fully understands MS and how it affects people's lives (not just their health). If you think you might benefit from her services, check out her website. Disclaimer: I am, in no way, benefiting by telling you about her services (She is not paying me or anything for this "plug"). She is just a friend who I believe can make a difference in people's lives and if you or someone you know could use help getting out of a "rut", then she may be able to help.
Ok, now onto the exciting news! If you didn't already know, the FDA approved teriflunomid, an oral therapy for relapsing forms of MS! The following excerpt was taken from the NMSS website (here):
The U.S. Food and Drug Administration has approved teriflunomide once-daily pills (Aubagio,® Genzyme, a Sanofi company) to treat relapsing forms of MS. This is the second oral disease-modifying therapy approved for the treatment of multiple sclerosis. The therapy is expected to be available for prescription by October 1, 2012 in the U.S. The company has also applied for regulatory approval in other parts of the world.The NMSS website also has some FAQs regarding teriflunomid and links to the various studies, the FDA press release, etc. Be sure to click on the link above to read this valuable information!
“We are greatly encouraged to see a new oral therapeutic option become available to people living with MS,” advised Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and incoming Chair of the National MS Society’s National Medical Advisory Committee. “As with any new therapy, the long-term safety of Aubagio will need to be carefully monitored,” he added. Dr. Timothy Coetzee, Chief Research Officer at the National MS Society agreed. “With the collaborative research underway around the world today, this is an extremely hopeful time for anyone who is diagnosed with MS.”
About Teriflunomide/Aubagio: Multiple sclerosis involves immune system attacks on the brain and spinal cord. Aubagio (pronounced oh-BAH-gee-oh) is a novel oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes), reducing the proliferation of T and B immune cells active in MS and also inhibiting the production of immune messenger chemicals by T cells. It is not thought to affect resting immune cells that are not in an activated state. Two doses (7mg and 14 mg) have been approved.
Potential benefits: Three large clinical trials of Aubagio have been completed, and at least two more are ongoing. In the phase III TEMSO study, Aubagio reduced the average number of MS relapses and disease activity on MRI scans significantly more than inactive placebo in 796 people with relapsing forms of MS.
In a recently completed phase III TOWER study involving 1,169 people with relapsing-remitting MS, oral Aubagio reduced relapses compared with placebo over at least 48 weeks, according to a company press release. Of two different doses tested during the TOWER trial (7 mg and 14 mg), the higher dose also slowed progression of disability.
In another study, called TENERE, Aubagio was compared with Rebif® (interferon beta-1a, EMD Serono and Pfizer) in relapsing MS, and did not reach its primary endpoint (the main question posed by the study) -- the “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. There was no significant difference in the numbers of participants who experienced events defined as treatment failure among the Aubagio and Rebif groups.
Potential risks and screenings: In trials to date, Aubagio was generally safe and well tolerated. The most common side effects experienced by participants in clinical trials include diarrhea, abnormal liver tests, nausea, flu, and hair thinning.
This is such exciting news! As someone who takes a once-daily injection, an oral therapy is extremely enticing! I have stayed away from Gilenya (the 1st oral therapy) because of the risks for pregnant women/ women who want to become pregnant. As you all now know, I recently had my first child. We have not decided whether more children are in our future yet, so I am hesitant to switch to an oral therapy until we are sure that we don't want more children. But, if I knew that we were done having kids, I would DEFINITELY be talking to my neurologist about possibly switching to one of these exciting oral therapies! I can't wait to hear more about how people do on the teriflunomid!
Sounds like the little man is waking up - back to MOMMY duty!