A new era of multiple sclerosis therapies begins as oral drugs come to market

New and improved multiple sclerosis (MS) drugs satisfying key unmet needs of oral administration and increased efficacy suggest a paradigm shift in MS therapy, and will end the decade long dominance of interferon betas and Copaxone (glatiramer acetate, from Teva) says independent analyst Datamonitor.

The Russian approval of German drug major Merck KGaA unit Merck Serono's Movectro (oral cladribine) is a landmark in the treatment for relapse-remitting MS (RRMS) patients, as it becomes the world's first oral disease-modifying MS therapy to be granted marketing authorization, so beating Novartis' Gilenia (fingolimod; The Pharma Letter July 12). Without Biogen Idec/Elan's Tysabri (natalizumab), and Novartis' Extavia (interferon beta 1b) launching, Movectro will become the first new MS therapy to enter the $200 million Russian MS market in over a decade - and this bodes well for European approval expected in the third quarter of 2010, says Datamonitor.

While winning the race for European approval, Datamonitor expects Movectro will lose out to Gilenia in the race to become the first oral MS therapy in the USA. In June 2010, Gilenia received unanimous backing by US Food and Drug Administration advisors to be approved for RRMS patients and this news comes as a blow to Merck Serono, days after it announced the resubmission of oral cladribine (TPLs passim).