Last week Sanofi SA’s oral drug for Multiple Sclerosis, Aubagio (also known as Teriflunomide and A77 1726), was approved by the FDA. Somehow this one snuck under my radar and here we are with it scheduled to be prescribed by October 1st!
First, the bad news: studies show that it’s no more effective than Rebif (and maybe less effective). With Gilenya already on the market and BG-12 looming, I doubt that this drug will make a huge impact. It is related to an existing arthritis drug, leflunomide.
The good news is that it does work compared with placebo and is generally safe and well-tolerated. Because it acts differently than interferons, it may also make patients less susceptible to infections. The more choices we have for treatment, the better.
How does it work?
- stops B and T cells (thought to cause disease progression) from dividing and multiplying.
- blocks the enzyme dihydroorotate dehydrogenase (this may prevent lesions)
- blocks the transcription factor NF-κB
- inhibits tyrosine kinase enzymes
Prior to starting Aubagio, patients should have a blood test to check liver enzymes and a Complete Blood Count. Blood pressure must be monitored and patients should be screened for tuberculosis.
After starting the drug, tests should be conducted monthly for the first 6th months and then monitoring should continue indefinitely for liver damage, infection, and blood pressure.
How Effective Is It?
While tests were conducted for doses in both 7 mg and 14 mg, it was the 14 mg dosage that has been approved.
- reduced relapses by 36.3% versus placebo
- time to disability progression was reduced by 31.5%
- reduced the average number of relapses in a year by as much as 31.5% over placebo
- total volume of tissue damage and active areas of damage were reduced significantly versus placebo
- higher patient satisfaction compared to interferon
Side Effects Of Aubagio?
- hair thinning
- back pain
- abnormal liver tests
- lowered levels of white blood cells
- increased blood pressure
- men or women planning to conceive should not take Aubagio
- Aubagio should not be taken by women who are pregnant
Would you be willing to take Aubagio? Are you happy with your current therapy?