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FDA Approves Lemtrada™ (alemtuzumab) for Relapsing MS – UPDATE

November 14, 2014

UPDATED December 18, 2014

The U.S. Food and Drug Administration has approved Lemtrada™ (alemtuzumab, Genzyme, a Sanofi Company) as a disease-modifying therapy for people with relapsing forms of MS. Lemtrada is given as intravenous infusions – for 5 consecutive days initially and for 3 consecutive days one year later. Because of its safety profile, the prescribing information indicates that use of Lemtrada should generally be reserved for people who have had an inadequate response to two or more MS therapies.

“The approval of Lemtrada provides an important and immunologically powerful new therapeutic option for people with relapsing MS,” said Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and Chair of the National MS Society’s National Medical Advisory Committee. “Its long-lasting effects may profoundly influence the course of relapsing MS, but will require careful and sustained monitoring for side effects which people receiving the medicine must follow. Individuals with MS who are considering treatment with this medicine should thoroughly educate themselves on its potential benefits and risks,” he added.

“The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States,” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “We are pleased that that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option.

About Lemtrada: MS involves immune system attacks against brain and spinal cord tissues. Lemtrada is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) and it causes depletion of lymphocytes (white blood cells). It was originally approved, at a significantly higher dose, for the treatment of B-cell chronic lymphocytic leukemia. Its ability to target immune cells led investigators to test its potential as a treatment for relapsing MS.

Lemtrada is given by intravenous infusion – for 5 consecutive days initially and for 3 consecutive days one year later. The prescribing information includes a boxed warning about the potential for serious or life-threatening autoimmune disorders, infusion reactions and malignancies. Lemtrada will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems.

Potential benefits: The FDA approved Lemtrada based on the results of two large, phase III clinical trials that confirmed its ability to significantly reduce relapse rates over two years over standard subcutaneous dosing of Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer). One of the studies also suggested that Lemtrada may significantly reduce worsening of disability. Alasdair Coles, FRCP (University of Cambridge) and Jeffrey Cohen, MD (Cleveland Clinic) and colleagues published the complete results of CARE-MS I and CARE-MS II in The Lancet (2012;380:2819, read more here).

  • In the CARE-MS I study, data were evaluated for 563 people with early, active relapsing-remitting MS, who had never received disease-modifying therapy to treat their MS and were randomly assigned to receive Lemtrada or Rebif. After two years the relapse rate for those on Lemtrada was reduced by 55% compared to those on Rebif. Also after two years, 8% of those on Lemtrada experienced an increase (worsening) in their EDSS score (a standard scale of physical disability) compared to 11 % on Rebif – a difference that was not statistically significant. After two years 78% of those on Lemtrada remained relapse-free, which was significantly more than the 59% who remained relapse-free on Rebif.
  • The CARE-MS II study was a two-year trial comparing Lemtrada to the standard subcutaneous dosing of Rebif. Data were evaluated for 628 people with relapsing-remitting MS who had already been treated with another MS therapy but had experienced at least one relapse on that previous therapy. After two years, the annual relapse rate for those on Lemtrada was 0.26 compared to 0.52 for those on Rebif, representing a 49% lower risk of relapses. In addition, on average fewer people on Lemtrada had an increase (worsening) in their EDSS score compared to those on Rebif (13% for Lemtrada vs. 21% for Rebif) – a 42% difference that was statistically significant. After two years, 65% of those on Lemtrada remained relapse-free compared to 47% on Rebif, which was also statistically significantly.

Potential risks: Prescribing information for Lemtrada includes a boxed warning about the potential for serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia (a rare bleeding condition) and anti-glomerular basement membrane disease (which impacts the kidneys). It also warns about serious and life-threatening infusion reactions (reactions occurring during or more than 24 hours after the administration of the medication), increased risk of malignancies (including thyroid cancer, melanoma, and blood cancers). Autoimmune thyroid disorders occurred in 34% of people treated with Lemtrada in clinical studies.

The most common adverse reactions noted in people who have taken Lemtrada include rash, headache, fever, nasal congestion, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, hives, itching, thyroid gland disorders, fungal infection, pain in joints, extremities and back, diarrhea, sinusitis, sore mouth and throat, tingling, dizziness, abdominal pain, flushing and vomiting.

FDA screening and monitoring recommendations: The FDA recommends that before starting treatment:

  • it should be determined whether the individual has been vaccinated for varicella zoster virus, and if not, tested for antibodies and vaccinated if needed 6 weeks prior to beginning treatment with Lemtrada;
  • thyroid function tests such as thyroid stimulating hormone level should be obtained before treatment and every 3 months until 48 months after the last infusion;
  • full blood count with differential should be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
  • serum creatinine levels should be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
  • urinalysis  with urine cell counts be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
  • skin exam should occur at start of treatment and yearly thereafter to monitor for melanoma;
  • people with active infections should consider delaying treatment until the infection is controlled.
  • People should not have live-virus vaccines after a course of Lemtrada.

Monitoring information and recommendations will be provided to individuals enrolled in the Lemtrada REMS program.

Before starting treatment with Lemtrada, women should talk to their health care providers if they are pregnant or planning to become pregnant.

Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

For more information about support services Contact Genzyme at 1- 855-MSOne2One.

Download the prescribing information (.pdf)

Read more about disease-modifying therapies and other treatments for MS and MS symptoms

Lemtrada is a trademark of Genzyme, a Sanofi Company.