Merck Serono resubmits cladribine as a potential MS therapy in USA; GSK/HGS file Benlysta in Europe

8 June 2010

Putting it back in the race to get US approval for an oral multiple sclerosis treatment, Merck Serono, a division of German drug major Merck KGaA, has resubmitted a New Drug Application to the Food and Drug Administration for cladribine tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

The company received a 'refuse to file' letter from the FDA for the cladribine tablets NDA in November 2009 (The Pharma Letter December 1, 2009), leaving Swiss major Novartis' oral MS drug candidate Gilenia (fingolimod; FTY720) in the lead. However, the latter drug has also seen a delay in FDA approval, after the agency - which has granted Gilenia priority review - last month extended its review period to September of this year (TPL May 26).

Regulatory filings for Cladribine Tablets are currently under review in a number of other locations including the European Union, said Merck.

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