Novo Nordisk, with data on-hand from a late-stage trial of IcoSema, is preparing for an FDA filing in type 2 diabetes slated for the second half of the year.
IcoSema is a combination of Novo’s insulin icodec and GLP-1 agonist semaglutide. Last week, the Danish drugmaker said the once-weekly injection achieved an average 1.6% reduction in the primary endpoint of change in HbA1c level at 52 weeks versus a 0.9% drop for insulin icodec.
The late-phase COMBINE-1 trial set IcoSema against insulin icodec in around 1,300 people with type 2 diabetes who are not adequately controlled on basal insulin. In a key secondary endpoint, participants given IcoSema also lost an average 3.7 kg (8.1 lbs) of body weight versus 1.9 kg (4.2 lbs) weight gain for people given insulin icodec. The company presentation did not disclose p-values, although Novo said the results were “statistically significant.”
COMBINE-1 is the last of three late-phase studies of IcoSema in type 2 diabetes to report data. The company revealed positive COMBINE-3 data in January and said it had “successfully completed” COMBINE-2 in its first-quarter earnings release.
Last month, the company’s insulin icodec was rejected by the FDA in type 2 diabetes due to questions about the manufacturing process. Novo said it won’t be able to fulfill the FDA’s requests on insulin icodec until after the end of the year. It is already approved with the brand name Awiqli in the EU, Canada, Australia and Japan.
The positive IcoSema results were the silver lining to an otherwise disappointing second-quarter report, with total company sales of 68 billion DKK ($9.94 billion) falling short of Barclays analyst projections of around 69 billion DKK ($10 billion).
Second-quarter sales of semaglutide products Wegovy and Ozempic also missed analyst expectations, coming in at 21 billion DKK ($3.1 billion) and 57 billion DKK ($8.3 billion), respectively. By contrast, Eli Lilly has been making GLP-1 market ground with Mounjaro, Zepbound and Trulicity accounting for around half of its $11.3 billion revenue in the second quarter.
Last week, Novo also pulled its US submission for Wegovy in heart failure with obesity after discussions with the FDA, with plans to have another go at label expansion next year when it has more data.
Editor’s Note: This article was updated to add more context on the COMBINE development program.