New Pill Gilenya Offers a Novel Approach to Managing Multiple Sclerosis, Focus Reports
Release Date: 2010-09-22
On September 22nd, the U.S. Food and Drug Administration approved the use of multiple sclerosis (MS) management drug fingolimod, marketed as Gilenya. Gilenya is produced by the Swiss pharmaceutical giant Novartis.While there is still no cure for the neurodegenerative disorder MS, Gilenya has been acclaimed as a “significant step” by the National MS society. In several years of clinical trials, the medication proved to significantly reduce incidences of relapse, and thereby slow the progression of the disease. Studies show that with each successive episode, the effects of the disorder become more debilitating; reducing relapse rates reduces the advancement of the disorder.
Gilenya is an orally-administered medication that comes in the form of a pill, and is the first such drug available in the U.S. market. Previous MS treatments in the U.S. were administered via injection. These drugs would often go unused, because of the difficulty inherent in administering them, and their range of painful side effects. Gilenya’s ease of use and tolerability are significant developments for MS patients in the country.
MS is an inflammatory disease affecting the central nervous system (CNS). It induces the immune system to damage the protective covering of nerve fibers in the CNS—including in the brain and spinal cord—causing neurological scaring, affecting the ability of cells to communicate, and generating a wide range of physical and cognitive symptoms. Gilenya represents a novel approach to MS treatment. It is thought to work by suppressing the immune system, and reducing the circulation and penetration of the immune cells that cause inflammatory damage to the CNS.
While the daily .5 milligram dosage approved by the FDA is considered relatively safe, the drug may induce some serious side-effects in users. Immediately after ingestion, Gilenya is known to reduce heart rate. Other side-effects may include acute infections, macular edema, and breathing and liver problems. The FDA did not approve higher dosages of the drug because they increased the risk of adverse effects without clearly increasing benefits. Dr. Robert P. Lisak of Wayne State University, and other physicians involved in the clinical trials, caution that further monitoring will be required for Gilenya users in the years ahead.
Gilenya is far from a cure for MS, but its effectiveness in managing the degenerative nature of the disorder, and relative ease of use, brings measurable relief to individuals afflicted with the disease.
| Type: | NORMAL |
| Company: | Focus Reports |
| Country: | Switzerland |