Guest guest Posted June 28, 2011 Report Share Posted June 28, 2011 Thanks for sharing that with us, Tina. The search for good meds continues! SharonThis email is a natural hand made product. The slight variations in spelling and grammar enhance its individual character and beauty and in no way are to be considered flaws or defects. To: mserslife <mserslife >Sent: Tue, June 28, 2011 10:07:44 AMSubject: No cladribine Cladribine is being withdrawn from testing. :(Tina---------- Forwarded message ---------- Date: Tue, Jun 28, 2011 at 11:55 AMSubject: National Multiple Sclerosis Society Research UpdatesTo: spydre74@... Email not displaying correctly? View it in your browser. Company Decides Not to Seek Approval of Cladribine for MSJune 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. 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: 1-. You are receiving this because you indicated an interest in research news and progress in the treatment of MS. Thank you for your ongoing support. -- The Gateway Area Chapter National MS Society | Legal Notice/Privacy Policy | Email Preferences | Unsubscribe National Multiple Sclerosis Society | 733 Third Avenue | New York, NY | 10017 Contact us at: http://mosmain.nationalmssociety.org/site/R?i=55Nma1x_PGO1B8bh2o-QGA.. or 1-. This message was sent to spydre74@.... To ensure that you continue to receive our emails, please add us to your address book. nonprofit software Quote Link to comment Share on other sites More sharing options...
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