Novo Nordisk could find out whether its long-acting insulin Tresiba can be sold in the US market as soon as October, the drugmaker told investors on Thursday, although it’s unclear whether the drug will secure favorable formulary placement from payers.
The FDA label “will determine how strong we are in the negotiations [with pharmacy benefit managers] and how strong we are in that competitive marketplace,” Lars Rebien Sorensen, Novo Nordisk’s president and CEO, told investors during the earnings call.
He said that Sanofi, the company’s chief rival in the long-acting insulin sector, had negotiated “good access” with the PBMs for its long-acting insulin Toujeo, but added that that access came with a lower price point. The FDA approved Toujeo in February.
Novo had resubmitted Tresiba for FDA review in April, after US regulators delayed the review in 2013. Tresiba is available in about 30 countries, although Novo recently announced plans to pull the drug from the German market over concerns with health authorities there about pricing.
The insulin market is becoming increasingly crowded. If Tresiba is approved in the US, it will be the newest competitor in a field that now includes Toujeo, Novo’s own Levemir and Sanofi’s market-leading basal insulin Lantus.
The Danish drugmaker reported that sales of its leading diabetes brands—Victoza and Levemir—generated double-digit growth in the first half of 2015 based on local currencies. Sales of Victoza rose 22% while sales of Levemir increased 10%.
Another Novo drug, Saxenda, recently received FDA approval as a treatment for obesity. Company executives said the decision by CVS Caremark, a large PBM, to give Saxenda, which is a lower-dose version of Victoza, a preferred position on its 2016 formulary alongside obesity drugs Belviq and Contrave is positive for the company but noted the obesity-drug market is still a challenging one. Sales of new obesity medications have flagged.
Novo reported that there had been 1,420 total prescriptions for Saxenda since its launch based on data from IMS Health.