Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lemtrada ( Alemtuzumab ) 12 mg in 1.2 ml ( 10 mg/ml ) concentrate for solution for infusion intended for the treatment of relapsing remitting multiple sclerosis.
The approved indication is: treatment of adult patients with relapsing remitting multiple sclerosis ( RRMS ) with active disease defined by clinical or imaging features.
Alemtuzumab is a humanized monoclonal antibody directed against the cell surface glycoprotein CD52. The mechanism by which Alemtuzumab exerts its therapeutic effects in multiple sclerosis is not fully elucidated. However, research suggests immunomodulatory effects through depletion and repopulation of lymphocytes.
The benefits with Lemtrada are its ability to reduce the relapse rate and slow disability progression.
The most common side effects are infusion associated reactions (including headache, flushing, nausea, urticaria, rash, pruritus, pyrexia and fatigue), upper respiratory tract infection, urinary tract infection, lymphopenia and leukopenia. In addition, side effects pertaining to the thyroid gland ( including over-active or under-active thyroid gland, or goitre and auto-immune conditions ) were commonly observed in patients treated with Alemtuzumab.
Treatment with Lemtrada should be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis. Specialists and equipment required for the timely diagnosis and management of the most frequent adverse reactions, especially autoimmune conditions and infections, should be available. Resources for the management of hypersensitivity and/or anaphylactic reactions should be available.
Patients treated with Lemtrada must be given the Patient Alert Card and Patient Guide and be informed about the risks of Lemtrada. ( Xagena )
Source: EMA, 2013
XagenaMedicine_2013
