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Adagio for Aubagio

Genzyme banking on safety, tolerability of oral Aubagio to compete in MS

When Sanofi's Genzyme Corp. unit launches multiple sclerosis drug Aubagio teriflunomide this month, its job will be to overcome physician sentiment that the drug's pregnancy restrictions and modest efficacy will relegate it to second- or third-line use.

The company is banking on the safety and tolerability of Aubagio to give the oral drug a leg up over first-line injectables.

On Sept. 12, FDA approved 14 mg and 7 mg once-daily Aubagio to treat relapsing-remitting forms of MS (RRMS). When it is launched in early October, the dihydroorotate dehydrogenase (DHODH) inhibitor will be the second oral drug to enter the MS space in the past two years.

In 2010, FDA approved Gilenya fingolimod from Novartis AG. The drug was approved in Europe the following year.

At the time, doctors expected uptake to be slow as they became acclimated to the cardiac profile of the oral once-daily sphingosine 1-phosphate (S1P) receptor agonist. Gilenya's original label recommended that doctors observe patients for six hours after the first dose for

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