Merck Serono resubmits oral MS therapy to FDA
Published on 08/06/10 at 12:14pm
Merck Serono has re-submitted its oral multiple sclerosis therapy cladribine to US regulators.
Merck Serono, a Swiss division of Merck KGaA, had previously been sent a ‘refuse to file’ letter from the FDA in November last year due to serious ‘omissions or inadequacies’ in the document submitted.
Cladribine is a small molecule that may interfere with the behaviour and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.
The drug is in fierce competition with Novartis’ MS oral therapy Gilenia, which recently received a boost from new trial data and has been awarded priority review status from the FDA.
This has however been pushed back by three months as the US regulator requires more time to analyse Gilenia’s trial data.
Ben Adams
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