Drug Development

It’s a tie: Sanofi and Novo come in neck-and-neck at the FDA with two new diabetes combo OKs

Sanofi and Novo Nordisk tried mightily to beat each other to the finish line first with a combination of their long-lasting insulin with their GLP1 drugs. But the FDA decided to call it a draw.

Olivier Brandicourt, Sanofi CEO

Olivier Brandicourt, Sanofi CEO

Regulators in the US simultaneously approved Novo’s Xultophy — a combination of Tresiba and Victoza on the market in Europe for the past two years — and Sanofi’s Soliqua, which combines Lantus and Lyxumia.

Xultophy’s edge encouraged analysts to project a blended $1.2 billion annual sales projection for 2021, as tracked by Thomson Reuters, while Sanofi may not hit half that amount.

Both of these companies represent the top ranks of big players which dominate the diabetes market. Intensely competitive, regulators tend to work at a slow and steady pace when it comes to their reviews. As a result, Sanofi squandered its $245 million priority review voucher on Soliqua, forced to take extra time to answer the agency’s question on its delivery device.

Both of these companies have had to suffer through declining expectations for their diabetes franchises. In Sanofi’s case, the setback on diabetes helped push them to partner closely with Regeneron in other areas. But (relatively) new CEO Olivier Brandicourt was left standing at the altar in his bid for Medivation and the partners’ first commercial product in PCSK9 has called far, far behind initial expectations as payers continue to refuse reimbursement.

You can expect both companies to hit the ground running in 2017. The US market remains the most important arena in the global drug market. And in diabetes, speed and competitive zeal is paramount. In addition, neither pharma company can afford to be lax in pursuing new sales.


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RAPS Regulatory Convergence 2017