Health Canada has approved Alemtuzumab. Alemtuzumab will be marketed by Genzyme as Lemtrada for the treatment of relapsing remitting multiple sclerosis (RRMS), with active disease, who have not shown an adequate response to interferon beta or other disease-modifying therapies.
Alemtuzumab is a monoclonal antibody which targets the CD52 protein. The drug was used for several years to treat leukemia patients under the name Campath. Genzyme acquired the rights to market the drug after study results showed that it can reduce MS relapses. Genzyme is currently providing Alemtuzumab free of charge to leukemia sufferers who did well under the Campath therapy.
The Alemtuzumab approval from Health Canada comes after the recent EU approval. There are still more approval applications under review in both the U.S. and Mexico.
In November 2013, An FDA advisory committee voted that Alemtuzumab has been shown to be adequately effective for the treatment of RRMS. However, the Peripheral and Central Nervous System Drugs Advisory Committee found that Genzyme has not provided enough substantial evidence of improvement in disability with Alemtuzumab. The committee’s findings were based on inconsistencies found in two studies of Alemtuzumab.
Lemtrada’s support is fueled by a clinical development program with about 1,500 patients and 5,400 patient-years of follow-up. Genzyme’s two pivotal trials, CARE-MS-I and CARE-MS-II, both showed that the drug reduced the yearly relapse rate in RRMS patients by approximately 50% vs. beta-interferon treatment, one of two standard therapies for the condition, the other is glatiramer acetate.
Lemtrada 12 mg has a novel dosing and administration schedule of 2 courses, 1 year apart. The first treatment is administered via IV infusion on 5 consecutive days, and the second course is administered on 3 consecutive days, 1 year later. Genzyme President and CEO David Meeker says “Lemtrada is now approved in 30 countries, and we are very pleased that Canadian patients and physicians will have access to this important new treatment option.”
There is still plenty of concern surrounding the dangerous side effects form taking Alemtuzumab. The most common of which are infusion associated reactions (headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills and flushing) and infections (nasopharyngitis, urinary tract and upper respiratory tract).
Autoimmune conditions, including thyroid disease, cytopenias, glomerulonephritis, and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.
Clinical safety reviewer Evelyn Mentari, MD, outlined several serious adverse events that occurred during the trials. In the two controlled trials of the drug, 18.5% of patients in the Alemtuzumab group experienced thyroid adverse events — including hyperthyroidism, hypothyroidism, Basedow’s disease, and autoimmune thyroiditis — versus 5.4% of the interferon patients. If the extension trial is included, 22% of all Alemtuzumab patients developed Graves’ disease, compared with 1% of patients on interferon.
Other side effects Mentari mentioned included immune thrombocytopenia (occurring in 2% of all patients treated with Alemtuzumab versus none of the patients on interferon) and pneumonitis (0.5% versus 0%). In addition, five cases of thyroid cancer occurred in female patients taking Alemtuzumab who were seen at sites in the U.S., which is equivalent to a rate of 298 cases per 100,000 person-years. The Surveillance, Epidemiology, and End Results (SEER) database reports that thyroid cancer incidence among all U.S. females is 18 per 100,000 person-years, she noted.
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