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SPRING MONEY, Md., March 26, 2019 / PRNewswire / – The US Food and Drug Administration today approved Mayzent (siponimod) tablets for the treatment of adults with relapsing multiple sclerosis (MS), including isolated clinical syndrome cases.
"Multiple sclerosis can have a profound impact on a person's life," he said. Billy Dunn, M.D., Director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research. "We are committed to continuing to work with companies that are developing additional treatment options for multiple sclerosis patients."
Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system that disrupts communication between the brain and other parts of the body. Most people have their first symptoms of MS between 20 and 40 years old. MS is one of the most common causes of neurological disability in young adults and occurs more frequently in women than in men.
For most people, multiple sclerosis begins with a recurrent-remitting course, in which episodes of worsening of function (recurrences) are followed by periods of recovery (remissions). These remissions may not be complete and leave patients with some residual disability. Many, but not all, MS patients have some degree of persistent disability that progressively worsens with time. In some patients, disability may evolve independently of relapses, a process called secondary progressive multiple sclerosis (SPMS). In the early years of this process, many patients continue to experience relapses, a phase of the disease described as active SPMS. Active SPMS is one of the recurrent forms of MS and approved drugs for the treatment of recurrent forms of MS can be used to treat active SPMS. Later, many patients with SPMS stop experiencing new relapses, but disability continues to progress, a phase called non-active SPMS.
The efficacy of Mayzent has been demonstrated in a clinical trial of 1,651 patients, comparing Mayzent with placebo, in patients with PMS with evidence of disability progression in the previous two years and none. recidivism during the three months preceding recruitment. The main evaluation endpoint of the study was the confirmed three month disability endpoint. The fraction of patients with a confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group. Mayzent also decreased the number of relapses suffered by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.
Mayzent should be exempted from the patient's medication guide, which describes important information about the use and risks of the drug. Mayzent may increase the risk of infections. Therefore, a complete blood count should be taken before initiation of treatment. The drug can cause macular edema. Patients should therefore contact their doctor if they notice a change in vision. Mayzent may cause a transient decrease in heart rate and impaired lung function. Hepatic enzymes should be checked before starting treatment and health care professionals should closely monitor patients with severe hepatic impairment. Health care professionals should monitor the patient's blood pressure during treatment. Women of childbearing potential must use effective contraception during and for 10 days following discontinuation of treatment because of the potential risk of harm to the fetus. Health care professionals should monitor patients with reversible posterior encephalopathy syndrome and patients treated with immunosuppressive / immunomodulatory agents because unintentional additive immunosuppression with Mayzent may occur.
The most common side effects reported by patients receiving Mayzent in clinical trials are: headache, high blood pressure, and increased liver function tests.
The FDA has approved Mayzent at Novartis.
Additional information:
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.
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Consumer Inquiries: 888-INFO-FDA
SOURCE US Food and Drug Administration
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