As some may have seen, Abagio the 2nd oral is now approved.
Important to note (my opinion) - When compared to Rebif. Don't mean to be skeptical my friends, I'm just the type of person who wants some comparisons to existing meds with track records.
News flash from the Society below:
"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"
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.
“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.”
Read the FDA’s press release.
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. Read more about this study.
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. Read more about this study.
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.
The prescribing information includes a boxed warning related to the potential for liver damage in persons taking Aubagio. There is also a warning that Aubagio is not indicated for women who are pregnant or women with childbearing potential who are not using reliable contraception. The prescribing information also contains information on how to clear Aubagio from the system in case that is required.
Before people begin taking Aubagio, they should have a blood test, of have had one within six months, to detect levels of liver enzymes and levels of blood cells (Complete Blood Count). They should also have their blood pressure checked, and have a screening test for tuberculosis (tuberculin skin test). It should be verified in women of childbearing potential that they are not pregnant before taking Aubagio.
After starting Aubagio, blood tests to detect liver enzymes should be done at least monthly for the first six months, and then patients should be monitored for signs of liver damage. Patients should also be monitored for signs of infection, and blood pressure should be checked periodically.
Here is the link if you've not seen it already.
Thanks for posting this Shell. You beat me to it! There is important information to be considered when considering the new oral drugs and their efficacy (how well they work) and the possible side effects.
Please read what Shell posted. It contains this important information.
Shel, thanks for posting this. I haven't been keeping up with the new medicines. Then at my last appointment a few weeks ago I was told to look at GB-12. The side effects are minimal and it doesn't suppress the immune system.
This could be a very exciting alternative to medicines that cause side effects and appears to be more effective than the injectables.
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