Use of Lemtrada (alemtuzumab) for the treatment of multiple sclerosis: measures to minimize the risk of serious adverse effects
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of the medicinal product Lemtrada (alemtuzumab) in patients with relapsing multiple sclerosis. The PRAC recommendations are based on a review of reports of rare but serious outcomes, including deaths, from immune-mediated conditions and serious disorders of the heart, circulation and bleeding, including stroke. Immune-mediated conditions can occur many months after treatment with Lemtrada, while serious cardiac, circulatory and bleeding disorders can develop within days after taking Lemtrada.
PRAC recommends restricting Lemtrada for use in adults with relapsing-remitting multiple sclerosis that is highly active despite adequate treatment with at least one disease-modifying therapy, or if the disease is worsening rapidly with at least two disabling relapses per year and new brain lesions detected on imaging. Lemtrada should also no longer be used in patients with certain heart, circulation or bleeding disorders, or in patients who have autoimmune disorders other than multiple sclerosis.
New measures were recommended for the detection and prompt management of adverse effects that may occur after treatment with Lemtrada. Lemtrada should be used only in healthcare facilities with access to resuscitation measures and specialists experienced in treating serious adverse reactions.
PRAC also recommends updating the guidance for physicians and the patient information in order to minimize the risk of serious heart, circulatory, and bleeding disorders that may occur soon after intravenous infusion of Lemtrada, as well as autoimmune conditions that may occur many months after the last treatment with Lemtrada.
The new recommendations replace the temporary measures adopted in April 2019 during the PRAC review. The PRAC recommendations will now be sent to the CHMP, which will adopt the Agency's final opinion.
More about the medicinal product
Lemtrada is a medicinal product used to treat adults with relapsing multiple sclerosis, in which the body's immune system destroys the protective sheath surrounding nerve cells. Relapsing-remitting means that the patient has relapses between periods with mild or no symptoms (remission). The drug is used in patients with active disease by intravenous infusion.
The active substance in Lemtrada is alemtuzumab (a monoclonal antibody), which was designed to recognize and bind to the CD52 protein found on white blood cells. By binding to CD52, alemtuzumab causes the destruction and replacement of white blood cells, thereby reducing the damaging activity of the immune system. Lemtrada was authorized in the EU in 2013.
More about the procedure
The review of Lemtrada was initiated on 10 April 2019 at the request of the European Commission, pursuant to Article 20 of Regulation (EC) No. 726/2004. The review was carried out by the PRAC Committee, which issued recommendations. The PRAC recommendations will now be sent to the CHMP Committee. The final stage of the review procedure is a legally binding decision of the European Commission for all EU countries.
Link to the EMA press releasehttps://www.ema.europa.eu/en/documents/referral/lemtrada-article-20-procedure-lemtrada-multiple-sclerosis-measures-minimise-risk-serious-side_en.pdf
"List of medicinal products containing lemtrada (State Register as of 23.10.2019)"
