Merck KGaA plans to re file cladribine tablets at EMA for treatment of relapsing multiple sclerosis.
Merck KGaA has announced that it intends to submit its investigational treatment cladribine tablets for the treatment of relapsing multiple sclerosis for registration in Europe. The decision follows the company�s evaluation of new data and additional analyses of the compound�s benefit-risk profile.
Merck KGaA, wound down its clinical development program for cladribine Tablets in 2011 after some regulatory authorities expressed concerns over the insufficient characterization of the drug's benefit-risk profile. Nevertheless, several large clinical trials were allowed to complete and additional safety information was alsocollected in a long-term registry.
Comment: Both the FDA and EMA rejected cladribine due to its safety risks and potential for cancer and the drug was withdrawn from the regulatory process which resulted in a massive reorganisation and loss of jobs at Merck.
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