Merck Serono No Longer Seeking Approval for Oral Cladribine

Cladribine Tablets were expected to be one of the next approved disease-modifying therapies to treat relapsing forms of multiple sclerosis (MS). Merck Serono announced on June 22, 2011 that they will no longer seek global approval for the drug.

This decision follows recent feedback from the United States Food and Drug Administration (FDA) as well as earlier feedback from the European Medicines Agency (EMA). Both agencies were looking for additional data, which would ultimately require the initiation of a new clinical trial program – and several years to conduct these new trials. In a news release from Merck Serono, the company states that it “will focus resources on other projects bringing benefit to patients with multiple sclerosis.”

Merck Serono will also be continuing its ongoing trials with the drug, given that the benefit and risk profile of Cladribine Tablets has not changed. Merck Serono plans to complete the initial 96-week treatment period for the CLARITY, EXTENSION, ORACLE MS, and ONWARD clinical trials. By completing these trials, the drug developer notes that the study participants will be able to continue in the trials and the findings will provide valuable information for the scientific community, which could potentially assist in the development of future treatments for the disease.

Cladribine Tablets are presently approved and marketed in Australia and Russia under the trade name Movectro®. Merck Serono will be withdrawing the product from the market in those countries. They will need to develop a timeline for discontinuing this drug and will help to determine the best treatment plan for individuals currently taking Movectro. Merck Serono will also withdraw its applications in other countries where it was seeking approval for Cladribine Tablets.

Merck Serono will continue with its PREMIERE registry as well. This program follows patients who have participated in the studies with Cladribine Tablets, providing additional safety information on the drug.

MSAA Chief Medical Officer Jack Burks, MD, expressed his disappointment over the loss of this drug as a candidate for MS treatment, but acknowledges the importance of adequate safety data. However, he looks on the bright side and explains, “Fortunately, we have several effective treatments that are of great help to many patients, plus, additional treatments will likely be available soon. As more treatments become available for MS, patients will be given more options for treating the disease. And this is so much better than 20 years ago, when there were no choices.”

Presently, eight approved disease-modifying therapies are available for the treatment of relapsing forms of MS in the United States. These include five injectable medications, two drugs that are given via IV infusion, and an oral medication for MS (approved in 2010).

Several experimental oral medications are in development for the treatment of MS and are getting close to seeking approval. Cladribine was among those expected to be approved in the near future. While the withdrawal of Cladribine Tablets is disappointing news for the MS community, we look forward to other advancements in MS research.

For more information, please refer to these articles from MSAA on cladribine:

Oral Cladribine Denied FDA Approval
FDA Extends the Review Period for Oral Cladribine

To speak with one of MSAA’s Helpline consultants, please call (800) 532-7667.

Written by Susan Wells Courtney, MSAA Senior Writer & Creative Director
Reviewed by Dr. Jack Burks, MSAA Chief Medical Officer