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FDA clears Sanofi's oral MS drug Aubagio

Will compete with Novartis’ Gilenya

Aubagio - Sanofi

Sanofi has become the second pharma company to bring an orally-active drug for multiple sclerosis (MS) to the US market after winning FDA approval for its Aubagio product.

Aubagio (teriflunomide) was given the go-ahead as a once-daily treatment for adults with relapsing forms of MS, and will compete in the marketplace with Novartis' oral MS drug Gilenya (fingolimod), which achieved sales of $494m in 2011, its first full year on the market.

A third oral MS candidate - Biogen Idec's BG-12 (dimethyl fumarate) - is also expected to reach the US market in the coming weeks.

Approval of Aubagio was given on the back of the TEMSO trial, which found that the relapse rate for MS patients treated with Sanofi's drug was around 30 per cent better than those receiving placebo. It was also significantly better at extending the time to disability progression over the two-year study.

"MS can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients," said Russell Katz, the head of the FDA's Division of Neurology Products.

Aubagio has been approved with a boxed warning on its label to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects, said the FDA.

Sanofi's drug is not considered to be quite as effective as its rivals in the oral MS treatment category, but has a favourable side effect profile that should guarantee a supporting role in the market, according to analysts.

Predictions of Aubagio's peak sales range from two or three hundred million dollars a year right up to blockbuster revenues of more than $1bn, depending on the analyst polled.

"We are greatly encouraged to see a new oral therapeutic option become available to people living with MS," said Bruce Cohen incoming chair of the National MS Society's National Medical Advisory Committee.

"As with any new therapy, the long-term safety of Aubagio will need to be carefully monitored," he added.

13th September 2012

From: Sales, Regulatory

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