lemtradaMultiple Sclerosis or MS is an incurable disease that attacks different people very differently. It can be managed and many people can lead a decent quality of life despite MS. Among the drugs used to treat MS are a range of steroids and certain disease modifying therapies, depending on the symptoms and severity of this disease. Sanofi has finally got FDA approval for a new drug, Lemtrada that has had a checkered 25 year history.

The drug and how it works

Lemtrada (alemtuzumab) is a monoclonal antibody. Since MS is a disease that attacks the immune system, a drug that can help the immune system, without suppressing it as interferon does, appears to have great potential as a treatment option.

Lemtrada does just that – it re-programs the immune system, thus increasing immunity and preventing relapses. Most MS drugs work only for the time that they are taken, but Lemtrada has a longer effect and a patient of MS may need treatment for up to three years for the efficacy of the drug to be optimal, though usually a two-year treatment is required.

Other drugs prescribed for MS

There are already a number of drugs in the market used to treat MS. Most of them work at preventing relapses of MS or decreasing the incidence of the disease progressing rapidly. The drugs that are in use as disease modifying therapies include:

  • Aubagio (teriflunomide) – also made by Sanofi – oral tablet
  • Avonex and Rebif (interferon beta-1a) injections; Avonex is a once a week injection given intramuscularly and Rebif is given thrice a week as an injection.
  • Betaseron and Extavia (interferon beta-1b); both are given every 48 hours as a self-injection.
  • Copaxone (glatiramer acetate) – daily injection
  • Gilenya (fingolimod) – oral tablet
  • Novantrone (mitoxantrone) – once in three months via intravenous
  • Tecfidera (dimethyl fumarate) – oral drug
  • Tysabri (natalizumab) – intravenous, given in a doctor’s office

Most of these work by trying to slow the disease progression in different ways.  Drugs like Cytoxan and Imuran work by suppressing the immune system and, while these do slow the disease, when the immune system is suppressed it can lead to other health problems and the patient needs regular monitoring to avoid serious complications. Cytoxan requires the patient to be at the treatment center for 3-4 hours as it is given by IV and also requires test pre and post treatment. Imuran tablets can be taken orally.

Pros and cons of the new drug

One of the main benefits of Lemtrada is that a great deal of time is saved: an MS patient has to take it for five days by IV just once. After that it has to be taken for three days after a gap of a year and then again for the third year if required. So it does not require daily or weekly oral medicines or injections, but consists of two or three courses.

While Lemtrada has been shown to be more effective in reducing the progression of MS as well as its relapses, many people also suffer from more side effects than those who are on interferon drugs. It may also work out to be quite expensive for patients and for the insurance companies.

Research studies

The first study of the phase III trials, CARE-MS I, showed that there was a 55 percent reduction in the relapse rate of MS after taking Lemtrada. This was done on patients who were new to MS treatments. Only 8 percent of the patients had an increased Expanded Disability Status Score. The CARE-MS II study, which was done on patients who had suffered relapses on different MS drugs, reinforced the efficacy of Lemtrada treatment: after a two-year treatment with the drug, patients had a 49 percent reduction in the relapse rate and 42 percent reduction in worsening of the problem. Additionally 80 percent of the patients did not receive a third course of Lemtrada.

The benefits of this treatment are hard to ignore. With 67 percent patients in the first study and 55 patients from the study remaining relapse free for a year, Sanofi’s new MS drug appears to have achieved a significant breakthrough in MS treatment. As the drug has only recently been FDA approved for MS treatment it will take time for doctors to review its results and efficacy on patient treatment away from clinical trials.

Lemtrada is not going to be cheap

As a pointer to drug companies making money out of disease, it is not like Lemtrada is a brand new drug. It was already being manufactured as Campath, though in a different dosage, and was used for treating leukemia patients. Some doctors were using it off-label to treat MS patients as well. Campath has now been withdrawn from the market in many countries and will be off the US list as well, though the company says that it will be available through patient access programs, free where possible.

Lemtrada is going to be launched as an MS drug and will be expensive, given that it does not have to be used in a dose like Campath or for a longer period of time. Its cost to the patient or the insurer is expected to cost $50,000 or more annually, compared to Campath’s price of $10,000 for off- label use in the same dosage. Campath had sales of $76 million in 2012 whereas Lemtrada has a projected market of $400-$600 million by 2018.

Sources:
Genzyme