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FDA Extends Trials for Cladribine

  • December 21, 2010
  • RPh on the Go

Cladribine is a new oral medication, manufactured by Merck KGaA, designed to treat patients with multiple sclerosis. This medication has been under intense scrutiny in both the United States and in Europe. The European regulators recently advised against approving the medication but the FDA feels the drug deserves a closer examination. This is significant because it was once thought to be a huge breakthrough for patients with multiple sclerosis, along with a rival medication Novartis which won approval from the FDA in September of 2010.

What does the drug do?

According to the manufacturer, Cladribine tablets offer a short course oral medication that can help patients with multiple sclerosis. In clinical studies, patients who had advanced MS had a reduced risk of lesions and had a reduced occurrence of disability.

How is it dangerous?

European authorities were most concerned with the link between Cladribine and cancer. They felt that the risks associated with using the medication far outweighed any potential benefit the medication might offer. However, there are some indications that the manufacturer is going to submit new data in an attempt to gain approval in Europe.


Prior to September, there were no alternatives for Cladribine. There were no oral medications for multiple sclerosis patients. However, in September of 2010, Gilenya was approved by the FDA and became the first medication available in the United States. It too is shown to slow the progression of the disease and reduce the risk of relapse. There are also other medications which are injected that provide similar benefits that are marketed by Merck KGaA, Biogen Idec, and Teva.

What to tell patients?

Many patients suffering from multiple sclerosis will likely be following the progression of these trials quite closely. They may have questions about the new medications. Print out a list of online resources from the FDA, the manufacturer, and even the regulatory agencies in the countries that have, or have not, approved the medication for them to peruse. It is always best to refrain from giving an opinion on a pending medication in order to not give false hope, and equally important, not take away hope. It is possible that the medical concerns surrounding the medication will be addressed and resolved and the medication will be available sometime next year. It is equally likely that the medication will not be made available in this country in the near future. Give the patients the information they need to learn more about the process on their own.

While European authorities are against the medication, both Australia and Russian agencies have approved it. With this extension, the manufacturer has until February 28, 2011 to gain approval from the FDA. What do you think of the studies that have been done on the medication? Do you think the FDA moves too slowly or too quickly in their process to approve or deny new medications?

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