- After months of elbowing each other in pursuit of being first-to-market for their respective diabetes drug combinations, Novo Nordisk and Sanofi saw their efforts effectively dashed on Monday, when the Food and Drug Administration approved both treatments on the same day.
- Novo Nordisk's Xultophy – a combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) – and Sanofi's Soliqua – a combination of Lantus (insulin glargine) and lixisenatide – are once-daily GLP-1/insulin injections for patients with type 2 diabetes.
- Novo plans to bring Xultophy to market within the first six months of 2017, while Sanofi expects Soliqua on store shelves by January.
While drug approvals are normally great news for pharmaceutical companies, the FDA's decision likely stung a little for Novo Nordisk and Sanofi. After all, the drugmakers worked hard to usher their products through the review process despite delays. Paris-based Sanofi even cashed in a priority review voucher it bought from Retrophin for $245 million with the intention of beating Novo Nordisk to market.
The same-day approval is a little less damaging to Novo Nordisk, given that Xultophy already got the green light from the European Commission in September.
Soliqua initially had a user fee date in August and received a positive recommendation from an Advisory Committee earlier in the year, but the PDUFA date was pushed back to November following an amendment in the application. Meanwhile, Xultophy's original approval date was in September and was pushed back to December. The same-day decision takes away any competitive advantage either company could have had.
The approvals will surely raise revenues for both competitors amid a challenging pricing environment for diabetes drugs. In a Nov. 22 note, Jefferies analysts anticipated peak sales of Xultophy to reach $1.7 billion and Soliqua to reach $1.5 billion.
"These basal insulin /GLP-1 combos are an important addition to the portfolios of both Sanofi and Novo Nordisk," the analysts wrote. "Not only do they provide improved glycaemic control, but they also provide an incremental opportunity to help build sales given the combinations' higher value versus the stand-alone products."
While the approvals were largely expected, there were some amendments to the Sanofi approval. The French drug maker initially sought approval for two different pens that offered the drugs in different ratios. It only gained approval for one with a consistent dose level that delivers 100 units/ml of insulin glargine and 33mcg/ml of lixisenatide. Previously, a low dose Soliqua pen had an insulin-to-GLP-1 ratio of 2:1, while a high dose pen delivered had a ratio of 3:1.
Novo Nordisk's Xultophy delivers 1 unit of insulin to 0.036mg of liraglutide.