#9 Oral Disease Modifying Treatment for Multiple Sclerosis

Overview

Multiple sclerosis, more commonly known as MS, is thought to be an autoimmune disease that causes the body’s immune system to mistakenly attack the central nervous system.

The central nervous system includes the brain, optic nerves, and spinal cord. It contains the nerves that act as the body’s messenger delivery system. Each nerve is covered by a fatty substance called myelin, which protects the nerves and helps in the transmission of messages between brain and other body parts.

MS gets its name from the buildup of scar tissue (sclerosis) located in more than one area of the brain and/or
spinal cord. “Sclerotic” plaques form when the myelin sheath is damaged, a process called demyelination. Without the protection afforded by myelin, signals transmitted throughout the central nervous system are then disrupted or halted. The process that damages the myelin also kills nerve fibers, leading to disability in many patients.

While not considered a fatal disease, MS affects 400,000 Americans and can ultimately lead to a variety of
transient or permanent symptoms, including blurred vision, loss of balance, slurred speech, extreme fatigue,
memory problems, paralysis, and blindness. In the most common variant of the ailment, patients have periods
of well-being followed by sporadic relapses.

MS cannot be cured, although there are seven FDA-approved drugs that can modify the course of the disease,
helping to lessen the frequency and severity of MS attacks, and reduce the accumulation of brain lesions.

MS drugs are effective, but they must be injected or infused on a regular basis, and this is enough to discourage
many people from consistently following through with their therapy, because of the bother and sometimes-painful
side effects. In order to increase patient treatment compliance, both patients and doctors alike have been asking for an effective oral alternative to add to the MS drug armamentarium.

Many years ago, Japanese researchers noted that a fungus discovered in the intestines of wasps could naturally
suppress immune responses. Refined into a chemical that could be used for people undergoing organ transplantation, this novel drug eventually failed in achieving that primary goal. Quite surprisingly, however, it was found that the drug could do something very important: blunt the immune system attacks in patients with MS.

After years of research and final testing, fingolimod was given a priority review reserved for groundbreaking therapies and was unanimously approved this year by the Food and Drug Administration as the first oral disease-modifying protection against MS attacks. The new capsule works differently from all other first-line MS therapies. By successfully preventing the migration of T cells from the lymph glands to the brain and spinal cord, it effectively keeps these marauding cells from attacking the fatty myelin sheaths that cover the nerve fibers.

Pivotal phase III clinical trials of the drug with 2,600 patients with relapsing forms of MS published in the New England Journal of Medicine reported that a daily dose of fingolimod reduced relapses by 60% annually when compared with placebo, and by 52% when compared with an injectable MS medication. In addition, MRI testing showed that patients treated with the drug had fewer brain lesions. Some patients experienced side effects with fingolimod and as a condition of its FDA approval, fingolimod will be studied globally for an additional five years to monitor its safety.

Although MS still has no cure, fingolimod capsules represent a big step forward in treating the underlying causes of this debilitating disease, slowing the progression of disability, reducing its frequency and severity, and ultimately improving the lives of people with MS.

Where Are They Now

Multiple sclerosis (MS) is thought to be an autoimmune disease that causes the body's immune system to mistakenly attack the myelin in the central nervous system. There are seven FDA-approved drugs that can modify the course of the disease, but they must be injected or infused on a daily or regular basis, and this is enough to discourage many people from consistently following through with their therapy because of the bother and sometimes-painful side effects. The new fingolimod capsules work differently from all other first-line MS therapies. By successfully preventing the migration of T cells from the lymph glands to the brain and spinal cord, the drug effectively keeps these marauding cells from attacking the fatty myelin sheaths that cover the nerve fibers. The drug represents a big step forward in treating the underlying causes of this debilitating disease, slowing the progression of disability, reducing its frequency and severity, and ultimately improving the lives of people with MS.

Approved by the FDA in 2010, fingolimod was approved for use in Europe and Canada in 2011. Long term study results of over 1600 patients were released in 2015 that confirmed it’s efficacy in treating multiple sclerosis patients. Currently, a study is in effect to test the possibility of recommending lower dosages to further minimize the side effects while still benefitting the patients. As of 2016, several new oral disease modifying drugs for MS were involved in clinical trials and have shown to be well-tolerated by patients. Positive results from one such trial has led to the EU Committee for Medicinal Products for Human Use (CHMP) backing of a novel long-delayed oral MS drug in June 2017.

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