MONDAY, April 1, 2019 -- Mavenclad (cladribine) tablets have been approved by the U.S. Food and Drug Administration to treat relapsing multiple sclerosis (MS) in adults.
An agency news release said the drug is recommended for people who have had an inadequate response to, or are unable to tolerate, another medication approved for MS. Mavenclad is not sanctioned for a form of MS called clinically isolated syndrome.
MS is a chronic autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. Most people have initial symptoms between ages 20 and 40, more often in women than men. The disease progresses over time and typically leads to lifelong disability.
Mavenclad's effectiveness was shown in clinical studies involving 1,326 people with relapsing forms of MS who had least one relapse in the prior 12 months. The drug significantly decreased the number of relapses compared to a placebo, the FDA said.
Mavenclad must be dispensed with a patient medication guide that describes the drug's uses and risks. The medication's label includes a boxed warning of increased risk of cancer, worsening existing cancer, and fetal harm. The drug should not be used in pregnant women and among people of reproductive age who do not use contraception during treatment and for six months afterward, the FDA said. Mavenclad should be stopped if the user becomes pregnant.
Other significant warnings include a risk of a drop in white blood cells called lymphocytes, infections, bone marrow suppression and liver injury. The most common adverse reactions include upper respiratory tract infection and headache.
Mavenclad is produced by EMD Serono, based in Rockland, Mass.
Visit the FDA to learn more.
Merck : Unit Gets FDA
Rashes, hair loss and lowered counts of another type of white blood cell, neutrophils, may also affect up to 1 patient. It contains the active substance cladribine. Lancet Neurol 2014; 13: 25767 vii, eU Clinical Trials Register. The European Commission (EC) granted marketing authorisation (MA) for plant compound could fight eye cancer Mavenclad meal Replacement Shakes Helped T2D Patients Shed Pounds in August 2017 and the drug was launched in all 28 European countries, including Norway, Liechtenstein and Iceland. Discovered and developed by Merck Group, it is one of the first approved oral short-course treatments. Mavenclad is a medicine used to treat adults with the relapsing forms of multiple sclerosis, a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord. Treatment for...
Mavenclad mechanism of action, mavenclad contains a selective immune reconstitution therapy that works by targeting B T lymphocytes. Effects on lymphocytes reduce the bodys immune defence against infections and cancer: Mavenclad must not be given to patients with active long-term infections such as tuberculosis or hepatitis, nor to patients with HIV infection or whose immune defences are. Symptoms of Multiple Sclerosis include fatigue, blurred vision and muscle stiffness. For more no Support for Pre-Op Antibiotics in Chest Port Placement information, see the package leaflet. In addition, the fact that Mavenclad is given by mouth, and requires only 2 short courses 12 months apart, offers an advantage to patients. For practical information about using Mavenclad, patients should read the package leaflet or contact their doctor or pharmacist.