MS drug, Ocrevus, delayed 3 months by FDA

KXAN’s Amanda Brandeis spoke with a patient with MS about how she has managed with MS (multiple sclerosis) and how this drug may be a benefit to others.   Dr. Greg Thaera, ADC neurologist with a special interest in MS, discusses how patients with Primary Progressive Multiple Sclerosis (PPMS) may benefit from this new drug.

The following is a transcript from KXAN:

AUSTIN (KXAN) — Mary Thompson says when she first learned she had Multiple Sclerosis (MS) in 1987, there were no treatments available. It all began when she woke up one morning and everything was blurry in her left eye.

“It is pretty terrifying when you don’t know whether it’s going to affect your walking, your eye sight, your brain,” said Thompson. “I have had it affect just about all my body parts. Now it is also affecting my brain, which is extremely difficult for me.”

Thompson and her husband have been in the beer business for years, starting the first microbrewery in southwest Texas. Her husband is now the Brewmaster at North by North West Restaurant and Brewery.

Because of MS, Thompson is no longer able to work in the brewery. She started a support group in Austin, connecting with others who live with the unpredictable disease of the central nervous system (CNS).

“Nobody understands MS like somebody that has MS. So it is very important to me to have people to talk to about it, moan about it, get angry about it, whatever,” said Thompson.

Many in the group have been looking forward to FDA-approval of a new treatment option, Ocrevus. The drug works by suppressing the immune system and would be the first treatment approved for patients with primary progressive Multiple Sclerosis (PPMS), which is usually more severe.

Dr. Greg Thaera is a neurologist at the Austin Diagnostic Clinic, who has patients eager to try the new treatment.

“The trials did prove positive, meaning that there was some benefit in prevention of long-term disability, which is actually a first for a Multiple Sclerosis drug, so it’s actually quite promising,” said Dr. Thaera.

But patients will now have to wait a bit longer for the drug. Ocrevus was expected to get FDA-approval by the end of the year, but it’s been pushed back another three months.

According to pharmaceutical company that created the drug, the extension is due to the manufacturing process, not the efficacy or safety of the drug.

“It’s the progressive forms of Multiple Sclerosis that at least at this time in 2016, we lack effective treatments for to halt the progression,” said Dr. Thaera.

“Some of them are desperate. We’ve had members of our group that have gone overseas to try and get some of the stem cell treatments,” said Thompson.

She herself has secondary progressive MS, and has tried several treatments over the years. She says many caused terrible side effects.

“The longer you’ve had MS and the more drugs you tried and the more drugs you hear about, you have a tendency to sit back and say, ‘Yeah, we’ll wait and see’,” said Thompson. “I’m hopeful, but hesitant.”

Dr. Thaera says the drug hasn’t yet proven to treat the type of Multiple Sclerosis Thompson has. But Thompson wants people to know that if you have MS it doesn’t mean your life is over.

“I think a lot of people fear MS is a death sentence, and it’s not. I’ve led an extremely happy life and I’ve been married 40 plus years, I have three wonderful children, two grandchildren.”

For Thompson’s friends and Dr. Thaera’s patients, they hope the wait is worth it.