EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.
After reports of immune-mediated conditions, the European Medicines Agency (EMA) announced on April 12, 2019 that its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety Lemtrada (alemtuzumab), which is used to treat multiple sclerosis. New side effects associated with Lemtrada included problems with heart, blood vessels, lungs, and liver in addition to the immune system not working properly in some patients.
PRAC is limiting the use of Lemtrada to adults with “relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used.” PRAC is also recommending that the product information be updated to include information about the new safety risks.
EMA is recommending the following to be included in the product information:
The agency is recommending that healthcare professionals consider stopping treatment if patients develop signs of any of the above conditions. EMA is evaluating all safety data and is considering any additional measures that may be needed.
Alemtuzumab is a monoclonal antibody designed to recognize and attach to protein CD52, which is found on white blood cells of the immune system. According to EMA, “by attaching to CD52, alemtuzumab causes the white blood cells to die and be replaced, thereby reducing damaging activity of the immune system.”
Source: EMA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.