Novo files once-weekly GLP-1 analogue semaglutide
Novo Nordisk has filed its once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide with regulators on both sides of the Atlantic, seeking permission to market the drug for the treatment of adults with type II diabetes.
The submission is based on the results from the SUSTAIN clinical trial programme involving more than 8,000 adults with type 2 diabetes, which studied the drug in combination with oral-antidiabetic agents and basal insulin and demonstrated significant and sustained blood glucose control.
For example, in the SUSTAIN 2 trial, from a mean baseline HbA1c of 8.1 percent, adults with type II diabetes treated with 0.5 mg and 1.0 mg semaglutide achieved superior HbA1c reductions of 1.3 percent and 1.6 percent, respectively, vs 0.5 percent with 100 mg sitagliptin at 56 weeks, as add-on to metformin and/or thiazolidinediones.
Also, in the SUSTAIN 3 trial, adults with type II diabetes and a mean baseline HbA1c of 8.3 percent achieved a superior HbA1c reduction of 1.5 percent when treated with 1.0 mg semaglutide vs 0.9 percent with 2.0 mg exenatide ER (p<0.0001), as add-on to one or two oral antidiabetics (metformin, sulfonylurea or thiazolidinediones).
SUSTAIN 5 showed that, from a mean baseline HbA1c of 8.4 percent, 397 adults treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significantly greater reductions of 1.4 percent and 1.8 percent, respectively, vs 0.1 percent percent reduction with placebo, when added on to basal insulin with or without metformin. Crucially, adults with type 2 diabetes treated with semaglutide achieved statistically significantly greater weight loss vs placebo (3.7 kg and 6.4 kg vs 1.4 kg) from a mean baseline body weight of 91.7 kg.
Also of note, the cardiovascular outcomes trial SUSTAIN 6 demonstrated a statistically significant cardiovascular risk reduction compared to placebo. According to the data, time to first occurrence of either cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 26 percent vs placebo, while there was a significant 39 percent decrease in non-fatal stroke after only two years of treatment.
On the safety side, Novo stressed that across the SUSTAIN clinical trial programme, once-weekly semaglutide had a safe and well tolerated profile with the most common adverse event being nausea.
"Achieving blood glucose control, weight loss and reducing the risk of cardiovascular events remains a significant challenge for adults with type II diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
"We are excited with this regulatory filing, as results from the SUSTAIN programme show that once-weekly semaglutide has the potential to further improve the treatment of adults with type 2 diabetes."
6th December 2016