FDA Approves First Ever Oral Multiple Sclerosis (MS) Treatment

Earlier this week, the United States Food and Drug Administration (FDA) officially approved the first ever oral drug that can be used to treat relapsing-remitting multiple sclerosis (MS), the most common form of the disease. Unlike current MS drugs, which are given by injections or infusion, the new drug, called Gilenya or fingolimod, comes in a capsule (pill) which is taken once a day.  Immediately following the approval, many within the health sector noted that this type of deliver – if effective – may revolutionize MS treatment. As many patients who rely on similar drugs can relate, taking a pill is much less painful than having to stick a needle in your body on a daily, weekly or monthly basis. According to a recent review provided by the FDA’s director of the Division of Neurology Products, what is unique about this drug is that it is the first oral drug which has shown the ability to slow the progression of this devastating disease while reducing the frequency and severity of the symptoms experienced by Multiple Sclerosis patients. What is also interesting, for shareholders of Novartis, is the potential revenues that this product could generate for the company, particularly if a large number of current MS patients switch to the less painful oral delivery product. Currently, Multiple Sclerosis affects about 2.5 million people worldwide, and approximately 400,000 in the United States alone.  Sadly, what causes MS is still unknown. Multiple Sclerosis is a disease of the central nervous system, where the body’s immune system attacks the fatty layer that protects nerves in the brain, spine and eye.  As the fatty layer is destroyed, scar tissue forms which blocks the nerve signals and leads to a variety of symptoms including difficulty walking, vision problems and/or pain.

While the new drug’s delivery method is exciting, what is more exciting is the drug’s performance in human trials. Back in January, during the final series of clinical trials, patients that consumed Gilenya along with Cladribine saw significant reductions in the rates of relapse. Specifically, administration of this drug orally cut the MS relapse rate by 62 percent in newly diagnosed patients and by 44 percent in previously treated patients. The oral version of the drug also slowed the progression of disability in patients. According to experts, unlike many other MS drugs, Gilenya is not an immunosuppressant.  Instead, it manipulates the immune system in a way that’s beneficial for patients with MS. While the results are promising, like many pharmaceutical drugs, consumers need to remain cognizant of the risks that consumption entails. Patients must not forget that the risks of consuming Gilenya in pill form are the same as those drugs consumed by injection. Oral consumption does not decrease the health risks & side effects. Moreover, like other MS drugs, Gilenya can induce a number of side effects including increased blood pressure, reduced lung function, eye toxicity, decreased heart function, and an increased risk of infection. The final questions surround uncertainty arising from the drugs performance in a large population. Since clinical human trials are small, no one can ultimately predict with certainty the drugs efficacy within the general population until it has been on the market for some time. While Novartis and the FDA are optimistic, Novartis has promised to set up a program to monitor and educate patients taking the drug.

Original Source: www.justmeans.com/FDA-Approves-First-Ever-Oral-Multiple-Sclerosis-MS-Treatment/31989.html