NDA of Cladribine as a drug for Multiple Sclerosis !

When I was working with Innovasynth Technologies, Khopoli, I worked in the field of "antisense drugs" and as the company has tie up with many MNCs (working with these class of compounds) I had many times interacted with Serono, Pharmaceuticals (US) for some of the intermediates (oligonucleotides). When I read this article, I am happy there are many drugs still to be established as antisense drugs and more over this NDA (new drug application) is something to cherish.

We know that 2-chlorodeoxyadenosine, Cladribine (Leustatin) is drug used to treat hairy cell leukemia (leukemic reticuloendotheliosis).

As a purine analog, it is a synthetic anticancer agent that also suppresses the immune system. Chemically, it mimics the nucleoside adenosine and thus inhibits the enzyme adenosine deaminase, which interferes with the cell's ability to process DNA. It is easily destroyed by normal cells except for blood cells, with the result that it produces relatively few side effects and results in very little non-target cell loss.

Though it has been used to treat leukemic reticuloendotheliosis, other activities like B cell leukemias and lymphomas, such as mantle cell lymphoma are still to be established. Now EMD Serono has applied for this NDA with FDA. As per the claim by the company, Cladribine Tablets has the potential to be the first orally administered disease-modifying therapy available for people living with relapsing MS, as all disease-modifying therapies currently approved for the treatment of MS are parenteral therapies. Hope FDA will approve the drug and will help many patients with relapsing forms of multiple scleorosis will have a relief in the days to come..

Ref : http://www.emdserono.com/cmg.emdserono_us/en/images/Cladribine%20Tablets%20FDA%20Submission%20FINAL%20US%20FINAL_tcm115_44365.pdf