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news.Merck KGaA has filed a new drug application (NDA) to the FDA for Cladribine tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Merck received a refuse to file letter from the FDA for the Cladribine Tablets NDA in November 2009.
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Merck Serono’s proprietary oral formulation of cladribine (Cladribine tablets) 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.
Regulatory filings for Cladribine tablets are currently under review in a number of other locations including the EU.
Merck Serono has evaluated Cladribine tablets in different trials, namely CLARITY (CLAdRIbine Tablets Treating MS OrallY) study, ORACLE MS (ORAl CLadribine in Early MS) study and ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study.