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12:00 AM
Oct 12, 2009
 |  BioCentury  |  Product Development

Sizing up the Oral Alternatives for MS

Sizing up the oral alternatives for MS

Two milestones were met late last month in the race to get the first oral treatment for multiple sclerosis to market: Merck KGaA submitted an NDA for its cladribine to treat relapsing-remitting MS; and Novartis AG reported Phase III data from a placebo-controlled trial of fingolimod.

While the data suggest both compounds are more efficacious than Copaxone glatiramer and the interferons that are used as first-line therapy for RRMS, safety issues could relegate them to second-line use along with Tysabri natalizumab, an injectable mAb against integrin alpha(4) that by one measure appears to be more efficacious than either of the pharmas' oral compounds.

Cladribine is a purine nucleoside analog that inhibits DNA synthesis, while fingolimod (FTY720) is a sphingosine 1-phosphate (S1P) receptor agonist.

Data from Novartis' Phase III FREEDOMS trial showed fingolimod resulted in 54-60% reductions in annualized relapse rate (ARR) and 30-32% improvements in physical disability as measured by the Expanded Disability Status Scale (EDSS) vs. placebo.

Those numbers were similar to data from Merck's Phase III CLARITY trial, in which cladribine showed 55-58% improvements in ARR and 31-33% improvements in EDSS over...

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