FDA expected to approve drug that halts multiple sclerosis in some patients – The Columbus Dispatch

JoAnne Viviano The Columbus Dispatch @JoAnneViviano

Nathan Frim calls Dr. Michael Racke a miracle worker.

The 44-year-old Frim, who has multiple sclerosis, used to take a pill every day, but his disease progressed.

In the past, there wasn't much Racke or other doctors could do. But along came a drug called ocrelizumab.

It's Racke's magic wand.

The drug, expected to be approved by the U.S. Food and Drug Administration today, has been shown to halt the disease in patients with both relapsing MS and primary progressive MS, said Racke, a neurologist at Ohio Sate University's Wexner Medical Center.

"It brings peace of mind," said Frim, who has relapsing MS. "Being on this medicine, I'm not worried about the progression. I feel that that's not an issue for me right now."

Further, the dosing schedule an infusion every six months gives him a reprieve from worrying about the disease that doctors discovered he had in December 2014. For days at a time, he said, he doesn't even think about having MS.

Frim, of Sunbury, received his latest dose of ocrelizumab on March 17.He's one of about 70 patients receiving the drug at Ohio State as part of clinical trials by drugmaker Roche and its subsidiary Genentech.

In multiple sclerosis, an abnormal immune-system response leads to an attack of nerve fibers and the fatty myelin that surrounds them in the central nervous system. As the brain is damaged, symptoms can include loss of coordination or strength, numbness, vision problems, slurred speech, loss of bladder control and cognitive difficulties.

Ocrelizumab works by depleting B cells, which are immune cells that participate in the attack on myelin, Racke said.

The drug represents a transformation in MS care, said Dr. Aaron Boster, director of the MS center at OhioHealth, where he also serves as systems medical chief of neuroimmunology.

Boster, who previously worked at Ohio State, also was involved in some of the clinical trials and said that data showing improvement in patients brought him to tears.

He said it's the first time there has been a B-cell killer to treat MS, likening the change in treatment options to the difference between a landline and a smartphone.

"Until recently, I was forced to look into someone's eyes and say 'I can make you get worse slower,' which breaks my heart," he said. "Emotionally, I can't begin to describe how important that is to me.

"I'm not a sports guy, but I now know what it feels like to have your team win."

Racke, who has been treating people with MS for more than 30 years, said that as treatments have progressed, he's seen fewer and fewer patients using canes and wheelchairs.

"Its not quite a cure yet, but if you start looking at some of the things coming down the pike, we're getting to the point where we're starting to say it's not going to be a cure for everybody; but for a lot of people, it's really gonna put the brakes on the disease," Racke said.

Frim's illness was diagnosed after he developed vision problems, making sense of a number of conditions he had attributed to the hard work he did growing up on a farm. He said he couldn't imagine going through the diagnosis and treatment without having been part of the clinical studies.

"It's very hopeful," he said. "For me, first prize would be no medicine, absolutely, but this is a close second, if there's a medicine that stops the progression."

jviviano@dispatch.com

@JoAnneViviano

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FDA expected to approve drug that halts multiple sclerosis in some patients - The Columbus Dispatch