About Alemtuzumab/LEMTRADA™

Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.

mar22, 2013

There was good news for French drug giant Sanofi this week as data from an extension study backed the long-term efficacy of its multiple sclerosis drug Lemtrada.

Interim data from the first 12 months of the extension trial showed that relapse rates and sustained accumulation of disability were low among patients previously treated with Lemtrada (alemtuzumab) in either of the two-year Phase III CARE-MS I or CARE-MS II studies.

In both these Phase III trials, Lemtrada was was given as an IV administration on five consecutive days, and the second course was administered on three days 12 months later.

After the first year of the extension arm, more than 80% of patients did not need further treatment with the drug, and more than half remained relapse-free through the first year of the extension study, the drugmaker said.

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H and currently under further development as Lemtrada) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and Islet cell transplantation.

Alemtuzumab binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are targeted for destruction.

Alemtuzumab is used as second-line therapy for CLL. It was approved by the US Food and Drug Administration for CLL patients who have been treated with alkylating agents and who have failed fludarabine therapy. It has been approved by Health Canada for the same indication, and additionally for CLL patients who have not had any previous therapies.

It is also used under clinical trial protocols for treatment of some autoimmune diseases, such as multiple sclerosis, in which it shows promise.^[1][2] Alemtuzumab was withdrawn from the markets in the US and Europe in 2012 to prepare for a higher-priced relaunch aimed at multiple sclerosis.^[3]

A complication of therapy with alemtuzumab is that it significantly increases the risk for opportunistic infections, in particular, reactivation of cytomegalovirus.

1. Drug may reverse MS brain damage”. 22 Oct 2008.
2. “Sanofi and Genzyme Report New Positive Data from First Phase III Study with MS Drug”. 24 Oct 2011.
3. “Sanofi withdraws Campath in US and EU”. Pharma Times Online. August 21, 2012.