FDA approves new drug to treat people with multiple sclerosis – WNDU-TV

Posted: Published on May 8th, 2017

This post was added by Dr. Richardson

The FDA has approved a new drug to treat people living with multiple sclerosis.

The chronic auto-immune disorder causes a patients own system to attack his or her brain and spinal cord.

The drug is not a cure for MS, but the treatment will allow some patients to live virtually symptom-free for the first time in years.

For 25 years, Pamela Arterbridge has been building her salon business one customer at a time.

Pamela said, I have a dedicated clientele and I never wanted to let them down.

Four years ago, she began feeling exhausted and developed symptoms she couldnt ignore.

I woke up one morning and all of my toes were numb and tingling and it felt like I had rocks in my shoes, said Pamela.

She had multiple sclerosis.

I have a lesion on my spine, and I have three on my brain, added Pamela.

Neurologist Michael Racke is an expert on MS at Ohio States Wexner Medical Center. He is one of a nationwide team of researchers studying the effects of a drug called Ocrelizumab.

Almost half the patients had no evidence of disease activity in terms of their MS," said Dr. Racke. "Thats much higher than weve seen with any other MS treatment.

Ocrelizumab is also the first drug ever available for the primary, progressive form of the disease, which effects about 15-percent of MS patients. The drug is given to all MS patients as an infusion.

Dr. Racke said, Patients receive it every six months, certainly a little bit more convenient than a monthly infusion or injection.

Pamela Arterbridge was on the drug for about a year as part of the clinical trial. She says its made all the difference.

I havent had the brain fog. I havent had any slurred speech," she said. "Im confident that Ill still be able to stand and do what I love to do.

Ocrelizumab is considered a first-in-class treatment, specifically targeting the B-cells, or immune cells, that play a large part in the disease.

MEDICAL BREAKTHROUGHS RESEARCH SUMMARY

TOPIC: MULTIPLE SCLEROSIS DRUG BANISHES SYMPTOMS! REPORT: MB #4255

BACKGROUND: Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord. In MS, the immune system attacks the protective sheath that covers nerve fibers and causes communication problems between the brain and the rest of the body. Eventually, the disease can cause the nerves themselves to deteriorate or become permanently damaged. Symptoms vary greatly between individuals, but may include numbness or weakness in limbs, double vision or loss of vision, tinging or pain in parts of the body, tremors, slurred speech, fatigue, dizziness, or problems with bladder and bowel function. The exact cause of MS is unknown, but risk factors include sex (women are more likely to develop it than men), family history, certain infections, race, climate, smoking, and certain autoimmune disorders. (Source: http://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/dxc-20131884)

TREATMENT: A new drug for MS has recently been approved and is making a difference for many who suffer from the disease. Ocrevus (generic name, ocrelizumab) is a humanized monoclonal antibody that was approved by the FDA on March 28, 2017. Ocrelizumab was developed by Genentech, a member of the Roche Group, as a treatment for people with MS. Ocrelizumab is the first FDA-approved therapy that treats both relapsing multiple sclerosis (RRMS) and, in a true breakthrough, primary progressive multiple sclerosis (PPMS), a disease form that previously had no approved treatments. Genentech had announced in February 2016 favorable results from a pivotal Phase 3 trial called ORATORIO, a randomized, double-blind, global, and multi-center study evaluating the efficacy and safety of ocrelizumab in 732 patients with PPMS. The drug was injected into the bloodstream as two infusions of 300 mg given two weeks apart every six months. At the end of the study period, it was seen that ocrelizumab had met the studys primary outcome, significantly reducing clinical disease progression in PPMS patients sustained for at least 12 weeks by 24% (compared to placebo). (Source: https://multiplesclerosisnewstoday.com/ocrevus-ocrelizumab-primary-progressive-relapsing-multiple-sclerosis/)

HOW IT WORKS: Ocrelizumab selectively targets CD20-positive B cells, a type of immune cell. B cells are thought to be a key contributor to myelin (nerve cell insulation) and nerve cell damage, which can result in disability for patients with MS. It is considered new because it is the first B cell targeting therapy that has had an impact on both relapsing and primary progressive MS and it is important because it is the first and only therapy that has an impact in primary progressive MS. (Source: http://www.cnn.com/2016/12/22/health/ms-drug-human-trial/)

FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT: Eileen Scahill 614-293-3737 Eileen.scahill@osumc.edu

Excerpt from:
FDA approves new drug to treat people with multiple sclerosis - WNDU-TV

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