Merck KGaA announced that the Australian Therapeutic Goods Administration (TGA) has approved Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS)(1). Cladribine Tablets will be registered in Australia under the trade name Movectro®.
"Approval of Cladribine Tablets in Australia is another step forward in our commitment to fight the devastating disease of multiple sclerosis by providing new therapeutic options meeting unmet needs," said Elmar Schnee, Member of the Executive Board and Head of the Merck Serono division. "Australia is the second country to approve Cladribine Tablets and we will continue our efforts to gain approval of Cladribine Tablets in other countries so that more patients can benefit from this oral disease-modifying therapy."
Cladribine Tablets, also under the trade name Movectro, became the first oral MS treatment in the world to gain marketing authorization when health authorities in Russia approved it in July 2010. Merck Serono initiated global submissions for Cladribine Tablets in mid-2009 and to date has submitted regulatory applications for Cladribine Tablets covering about 40 countries.
(1) The indication approved by the TGA is: "Movectro is indicated for the treatment of relapsing-remitting multiple sclerosis for a maximum duration of two years."
About Cladribine Tablets
Merck Serono's oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS. Merck Serono initiated global filings for Cladribine Tablets in mid-2009 and, to date has submitted regulatory applications for Cladribine Tablets covering about 40 countries. Cladribine Tablets was granted its first marketing approval in July 2010, in Russia.
The clinical development program for Cladribine Tablets includes:
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1 comments:
Cladribine, while having a lower overall side effect profile than Fingolimod, is still not considered a safe first line of defense drug for MS. All of the MS neurologists with whom I have spoken and the general concensus at the CMSC (Consortium of Multiple Sclerosis Centers) annual meeting in June, have voiced that the two oral meds awaiting approval (Cladribine and Fingolimod) have more serious and potentially disabling side effects than any of the injectable medications and will probably only be used as "rescue" drugs for those who have failed the injectable medications, Tysabri and Novantrone.
The risk of death from reactivated herpes infections is higher than that of PML in Tysabri with Fingolimod and severe infection of any sort with Cladribine is much higher than the risk of PML with Tysabri.
Although there are no injection site reactions, the flu-like symptoms and alteration of liver function are higher with fingolimod than any of the interferons and Cladribine suppresses the immune system and reduces the body's ability to fight infection for a period of 8-18 months with no known means to reverse this infection risk.
Please read research and side effects thoroughly before asking your doc to prescribe these medications.
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