NICE grants cladribine accelerated access for treating highly active MS. The Technology Appraisal Guidance (TAG), which is effective immediately, will soon state that the MS drug can be used as an option for treating highly active versions of the disease in adults without the requirement of a gadolinium-enhanced MRI scan. 
Approved in US for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS) 
Re-submission accepted by the FDA .
NHS England announce a deal with Merck to make cladribine routinely available on the NHS, allowing early access to the drug for patients. Patients and clinicians can access the treatment with immediate effect, and will not have to wait the usual 3 months after NICE publishes its final guidance to access cladribine .
Launched in UK 
Approved in EU .
EU positive opinion for treatment of adult patients with highly active relapsing MS as defined by clinical or imaging features .
Merck announces that the EMA has accepted the Marketing Authorisation Application for this indication. The submission includes data from three Phase III studies, CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537) and ORACLE MS (NCT00725985), and the Phase II ONWARD study (NCT00436826) .
Merck announces it intends to submit a licence application for cladribine for treatment of relapsing MS to the EMA, following evaluation of new data and additional analyses of the compound’s benefit-risk profile. Merck has submitted a letter of intent to the EMA. .
Merck have stated that due to U.S. drug regulators´ concerns about the risks of cladribine, any development or marketing plans for it are unlikely. Cladribine will also been withdrawn from Australia and Russia. Data from ongoing clinical trials are very unlikely to address the US FDA´s requirements. 
Not approved in US; the FDA has issued a complete response letter requesting the Company provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies .
EU filing withdrawn .
EMA has confirmed its previous negative opinion and adopted a final negative opinion, recommending that cladribine should not be granted a marketing authorisation .
US FDA review date extended to 28th Feb 2011. 
Merck is to ask the EU CHMP to review its negative opinion .
The CHMP of the European Medicines Agency has adopted a negative opinion, recommending that cladribine should not be granted a marketing authorisation for MS. The decision is due to concerns over an increased number of pts developing cancer in trials with cladribine, which may indicate an increased risk of cancer over time and with increasing doses. The CHMP also noted that the benefits & the most appropriate dosage had not been fully established .
Approved in Australia (trade name Movectro) 
Approved in Russia for treatment of relapsing-remitting MS. 
Granted a priority review in the US; the FDA decision on approval expected 4Q 2010 .
Filing re-submitted in the US .
Merck Serono are preparing a re-submission to the FDA (11).
FDA will not consider the licence application for cladribine in relapsing-remitting MS, pending the availability of further data (10).
Filed in the US. US launch anticipated Q2 2010; EU launch planned for Q4 2010 (9).
US filing expected this month .
Filed in EU. US filing expected soon .
Submissions for EU and US licence planned for mid-2009 for relapsing-remitting MS based on positive results from CLARITY (5)
PIII (oral) (1). Enrollment into PIII expected to be complete by end 06 (2). Fast track in US (3)