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SPRING MONEY, Md., March 29, 2019 / PRNewswire / – The US Food and Drug Administration today approved Mavenclad (cladribine) tablets for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including relapsing remitting illnesses and active secondary progressive disease. Mavenclad is not recommended in MS patients with clinically isolated syndrome. Because of its safety profile, the use of Mavenclad is generally recommended in patients who have had an insufficient response or are unable to tolerate another drug indicated in the treatment of MS.
"We are committed to supporting the development of safe and effective treatments for multiple sclerosis patients," he said. Billy Dunn, M.D., Director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research. "The approval of Mavenclad represents an additional option for patients who have tried another treatment without success."
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.
The effectiveness of Mavenclad has been demonstrated in a clinical trial conducted in 1,326 patients with recurrent forms of MS who had at least one relapse in the past 12 months. Mavenclad significantly decreased the number of relapses suffered by these patients compared with placebo. Mavenclad also reduced the progression of disability compared to placebo.
Mavenclad should be exempted from the patient's medication guide, which describes important information about the uses and risks of the drug. Mavenclad has a Boxed Warning for an increased risk of malignancy and harm to the fetus. Mavenclad should not be used in patients with common malignancy. In patients with prior cancer or an increased risk of cancer, health professionals should evaluate the benefits and risks of using Mavenclad on an individual basis. Healthcare professionals should follow the standard recommendations for cancer screening in patients treated with Mavenclad. The drug should not be used in pregnant women or women and men of childbearing potential who do not plan to use effective contraception during treatment and for six months after treatment because of the potential danger to the fetus . Mavenclad should be stopped if the patient becomes pregnant.
Other warnings include the risk of decreased numbers of lymphocytes (white blood cells); lymphocyte count should be monitored before, during and after treatment. Mavenclad can increase the risk of infections; health professionals should look for patient infections and treatment with Mavenclad should be delayed if necessary. Mavenclad can cause haematological toxicity and bone marrow suppression. Health professionals must therefore measure the complete blood counts of the patient before, during and after treatment. The drug has been badociated with a graft-versus-host reaction after blood transfusions with unirradiated blood. Mavenclad may cause liver damage and treatment should be discontinued or discontinued, as appropriate, if clinically significant liver injury is suspected.
The most common side effects reported by patients treated with Mavenclad in clinical trials are: upper respiratory tract infections, headache and decreased lymphocyte counts.
The FDA has approved Mavenclad's approval by EMD Serono, Inc.
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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SOURCE US Food and Drug Administration
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