Company Decides Not to Seek Approval of Cladribine for MS
June 22, 2011
Merck Serono announced today that it has decided not to pursue approval of its oral therapy Cladribine for the treatment of relapsing forms of multiple sclerosis. According to a company press release, discussions with the U.S. Food and Drug Administration made it apparent that the ongoing clinical trials of the therapy would not address the FDA’s requirements for approval. Details of these requirements have not been made public.
In March 2011, the company received a letter from the FDA indicating that its application for approval was not ready in its current form and outlining requirements for additional information. (Read more) The company has stated that it plans to complete the current clinical trials and patient registry that are underway, and that results will be published.
“It’s disappointing that completion of the Cladribine trials will not lead to approval of a new therapy option for people living with MS,” says Dr. Timothy Coetzee, Chief Research Officer at the National MS Society. “However, thanks to the many people who participated in these clinical trials, results from these studies will add to the body of knowledge about MS and should help spur new leads toward stopping MS, reversing its damage and ending MS forever.”
Additional therapies, including oral therapies, are currently making their way through the development pipeline. Read more (.pdf)
Individuals who have questions may contact MS Lifelines at the company’s toll-free phone number: