Lemtrada Approved by FDA

At 9pm on November 14th we got the news that many people have been waiting for, Alemtuzumab (Lemtrada) was approved by the FDA! This means there are now 12 FDA approved treatments for relapsing-remitting multiple sclerosis. Lemtrada was denied approval by the FDA in December, 2013 due to insufficient proof that its risks outweighed its benefits. Genzyme, a Sanofi company, argued that the side effects that occurred during clinical trials were all non life-threatening, treatable conditions. However, the FDA also disapproved of the design of the clinical trials because the patients knew whether they were taking Lemtrada or Rebif. Again, Genzyme argued that it would be nearly impossible to do a double-blind study because Rebif is given as an injection three times a week and has very obvious side effects, whereas Lemtrada is given as a set of IV infusions that are given one year apart. Genzyme decided not to conduct more clinical trials, and filed an appeal instead. Meanwhile, a petition in support of Lemtrada’s approval was circulated and signed by over 9,000 people living with MS.

Originally Lemtrada was a drug called Campath, and was used to treat leukemia. Once researchers learned that it would be an effective treatment for MS it was pulled off the market as a cancer treatment. It was then rebranded as an MS drug, which is a much more lucrative pharmaceutical market. It is estimated that the cost of the two rounds of therapy will be $158,000. It is predicted that Lemtrada could be a “blockbuster” drug, and eventually bring in $1 billion annually for Sanofi. Currently, Lemtrada is approved in over 40 other countries, but the US would be the largest market by far.

Much like Tysabri which is produced by Biogen, Lemtrada is a monoclonal antibody. It targets CD52 which is a protein on T and B cells. The end result is the depletion of T and B cells, which in turn decreases the migration of inflammatory cells into the central nervous system. In the first clinical trial, CARE-MS I, Lemtrada and Rebif were compared. Lemtrada was 55% more effective at reducing annual relapse rate then Rebif was. Additionally, at the end of two years 78% of people taking Lemtrada and 59% of those taking Rebif were relapse free. In the second clinical trial, CARE-MS II, Lemtrada was shown to reduce disability progression 42% more effectively then Rebif.

Lemtrada is an IV infusion that is given in two rounds. The first round is given once a day for five days, then the second round consisting of three consecutive infusions is given one year later. Studies show that these two infusions are all most patients will require, meaning they won’t have to take other drugs for at least three years from the time of the first infusion. The safety and efficacy of giving additional infusions has yet to be determined.

Much like other MS medications, Lemtrada has an extensive list of side effects. These include, hypotension, infections, cardiac effects, autoimmune conditions, and infusion reactions. The incidence of side effects makes it the most risky drug on the market right now, so it will be reserved for patients who have failed other therapies. Much like Tysabri, only specialized physicians who are registered with a special program will be able to prescribe Lemtrada, and close monitoring will be required.

Although the side effects certainly warrant extreme caution, many people living with MS strongly feel that it deserves to be a treatment choice. They argue that the decision should be made by doctors and by those who would be taking the drug, not by the FDA. There are many people with RRMS who have already failed most therapies, and who cannot take Tysabri. For them Lemtrada is the option that they have been long awaiting. What do you think?

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