FDA approves new, once-daily oral medication for MS patients

In autumn of 2009, Ali Salama was training for the ING New York City marathon and felt some numbness in her legs.

Originally, she attributed the problem to shin splints and took a break.   But the pain wasn’t going away, so she decided to see a neurologist.

At the age of 35, Salama was diagnosed with multiple sclerosis, a disease which has no cure and affects 2.5 million people around the world. The autoimmune disorder attacks the body’s nervous system and can lead to numbness, paralysis and loss of vision.


Salama said she was shocked.

“You read about it.  You obviously go on websites, (and) you see that people are in wheelchairs and how mobility becomes more difficult,” Salama said. “There’s vision issues, so all those things run through your mind.”

Salama said she wondered about the treatment and became fearful when she learned many treatment options included something she always hated – shots.

Dr. Aaron Miller, medical director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mt. Sinai School of Medicine in NYC and Salama’s doctor, said he was primarily prescribing injectable medications for his patients.

“These, of course, have been uncomfortable to say the least, and modestly effective,” he added.
Salama said she would always ask Miller if there was an oral medication she could take, but each time she asked, she would be disappointed by his answer.

Finally, her wish came true. A new, once-daily oral medication called Aubagio was approved by the U.S. Food and Drug Administration in September 2012 for patients with relapsing forms of MS.

“I think I high-fived him,” Salama recalled about learning of the drug from Miller. “I was really excited about it, because I knew it would change my routine emotionally and mentally.  Giving myself the injection reminds me that I have MS every day, when otherwise I don’t feel sick.”

The drug has a boxed warning, according to the FDA, because it could increase the risk of liver problems, death and a risk of birth defects. Doctors should check patients’ liver function before and during treatment.

The boxed warning also notes that animal studies showed the drug may cause fetal harm, so the drug is labeled as Pregnancy Category X. This means pregnant women should not take Aubagio, and women should have an effective form of birth control while taking the medicine, according to the FDA.

Other side effects of the drug include hair loss, influenza, diahrrhea and numbness of the skin, accord to Sanofi SA, which manufactures the drug.

The ongoing Aubagio clinical development program involves more than 5,000 patients in 36 countries. Some patients in extension trials have been treated for up to 10 years, the company said.

Miller said on average, people who take the new oral medication have approximately a one-third reduction in the frequency of their relapses. In addition, they have a significantly lower chance of developing a progressive neurological disability, he said.

“To just not have to plan every other night when I do the shot and not have the pain or tears every time I do it will be life-changing for me,” Salama said.

To learn more, visit msonetoone.com.

Reuters contributed to this article.