Novo refuses to give up on insulin Icodec, eyes combo filing with semaglutide
Novo refuses to give up on insulin Icodec, eyes combo filing with semaglutide
Despite last month’s FDA rejection of its once-weekly insulin infusion, Novo Nordisk will push through with a filing for its investigational IcoSema this year, proposing the combination of insulin icodec with its blockbuster GLP-1 inhibitor semaglutide for the treatment of type 2 diabetes.
During last week’s second-quarter 2024 earnings results, Executive Vice President for Development Martin Holst Lange told analysts on a call that Novo is gearing up “to file for regulatory approval for IcoSema during the second half of 2024.”
The decision follows the completion of the pivotal Phase III COMBINE-1 study, Lange said, noting that the combo therapy “achieved its primary endpoint” by showing superior blood sugar control after 52 weeks versus insulin icodec alone. COMBINE-1 ran for 52 weeks and enrolled nearly 1,300 type 2 diabetes mellitus patients with inadequately controlled disease.
According to Novo’s Q2 presentation, IcoSema reduced baseline HbA1c levels by 1.6 percentage points, compared to only 0.9 percentage points for those patients who were treated with insulin icodec alone. The combo treatment also cut body weight by 3.7 kg, while control counterparts gained 1.9 kg after treatment with icodec alone.
The Danish pharma did not provide p-values but nevertheless claimed that IcoSema’s effects were statistically significant.
