12:00 AM
Oct 01, 2012
 |  BioCentury  |  Product Development

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 decreases in heart rate (see BioCentury, Sept. 27, 2010).

Following a report of a patient dying within 24 hours of taking the drug, FDA updated the label to recommend that all patients receive an echocardiogram prior to starting the drug and six hours after the first dose in addition to hourly blood pressure and heart rate measurements(see BioCentury, May 28).

Novartis recorded sales of $530 million for Gilenya in 1H12, compared to $138 million in 1H11. But doctors contacted by BioCentury in September continued to express hesitancy in prescribing the drug given the upfront cardiovascular monitoring requirements.

Aubagio doesn't have the CV risks seen with Gilenya. The most common adverse events in the clinical program for Aubagio were headache, diarrhea, nausea, alopecia and influenza.

However, the label includes a boxed warning about potential hepatotoxicity and teratogenicity.

According to the label, severe liver injury, including fatal liver failure, has occurred in patients taking the generic rheumatoid arthritis drug...

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