Sanofi launches insulin combo Soliqua in US

Sanofi has launched new diabetes combination therapy Soliqua in the US ahead of a rival product from Novo Nordisk.

Soliqua (insulin glargine/lixisenatide) reaches the market ahead of Novo Nordisk's rival combination Xultophy (insulin degludec/liraglutide), which had been expected to launch first but was delayed by an extension to its FDA review.  In the end, both drugs got the green light from the US regulator on the same day last November.

The two rival drugs are once-daily injections which combine a long-acting basal insulin with a GLP-1 agonist and are intended for the treatment of patients with type 2 diabetes who are not managing their blood sugar levels effectively on single-agent therapy.

They are being billed by analysts as having substantial sales potential – which would be welcome relief for both Sanofi and Novo Nordisk as they have been facing stiff competition in the insulin sector, although payer pushback could make uptake slow.

Consensus analyst estimates polled by Thomson Reuters give Xultophy an edge with sales of $1.2bn in 2021, with Sanofi's product making $550m in that year.

Much will depend on the reception by big pharmacy benefit managers such as Express Scripts and CVS Health, which have resisted including drugs that offer improved convenience on formularies without steep discounting. And with two competing drugs with similar clinical profiles to play off against each other, negotiations for formulary positions are expected to be tough.

Sanofi said its Soliqua is now available in US pharmacies and has been introduced with a wholesale acquisition cost (WAC) price of $127 for a 300 unit pen. That equates to $19.90 per day at the dose administered in clinical trials, which Sanofi previously said was roughly in line with the daily cost of the GLP-1 agonist drugs.

For its part, Novo Nordisk has previously said it intends to launch Xultophy in the first half of 2017, and intends to price the drug at a 20% discount to the combined price of its two constituent drugs - which could make it more expensive than Soliqua.

Soliqua is also expected to be approved in Europe very shortly, having picked up a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) in November 2016. Xultophy is already available in Europe under the IDegLira trade name, but Novo Nordisk has not yet broken out any sales figures for the drug.