Novo Nordisk recently announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for semaglutide 2.4mg subcutaneous injection formulation. is a once-weekly glucagon-like peptide-1 (GLP-1) analog for long-term weight management. It is worth mentioning that Novo Nordisk also submitted a Priority Review Voucher (PRV) to accelerate the NDA review, which can shorten the NDA review cycle from the standard 10 months to 6 months.
The indication for semaglutide 2.4mg subcutaneous injection is: as an adjunct to a low-calorie diet and intensive exercise, for the treatment of obesity (BMI ≥ 30kg/m2) or overweight (BMI ≥ 27kg/m2) with at least one body weight Adult patients with relevant comorbidities.
This application is based on the results of the STEP Phase 3a clinical trial program. The project involved more than 4,500 obese or overweight adult patients. In the STEP program, weight loss was statistically significant and superior to patients who received 2.4 mg of semaglutide once weekly subcutaneously compared to patients who received placebo. In STEP 1, 3, and 4 trials, semaglutide 2.4mg for 68 weeks resulted in a 15-18% weight loss in patients. In addition, semaglutide 2.4 mg once weekly has a good safety and tolerability profile. The most common side effects were gastrointestinal reactions, which were transient and mild or moderate in severity. (For detailed efficacy data, see the Bio Valley article: 18.2% weight loss in 68 weeks! Novo Nordisk GLP-1 agonist semaglutide weight loss phase III STEP project 4 trials were all successful!)
Mads Krogsgaard Thomsen, executive vice president and chief scientific officer at Novo Nordisk, said: “Obesity is associated with a variety of serious complications, yet many healthcare providers still do not have adequate medical options to help patients with this chronic condition. We Excited about the regulatory filing for semaglutide 2.4mg in the U.S., we believe that once-weekly semaglutide 2.4mg has the potential to transform the medical management of obesity.”
Semaglutide is a human glucagon-like peptide-1 (GLP-1) analog, which stimulates insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent mechanism. Significant improvement in blood sugar levels and a lower risk of hypoglycemia in patients with type 2 diabetes. In addition, semaglutide was able to induce weight loss by reducing appetite and reducing food intake. In addition, semaglutide was able to significantly reduce the risk of major cardiovascular events (MACE) in patients with type 2 diabetes.
Obesity is a chronic disease that requires long-term treatment and is associated with many serious health consequences and reduced life expectancy. Obesity-related complications are numerous, including type 2 diabetes, heart disease, obstructive sleep apnea, chronic kidney disease, nonalcoholic fatty liver disease, and cancer.
Novo Nordisk is currently investigating a weekly subcutaneous formulation of semaglutide 2.4 mg as a treatment for obesity in adults. Semaglutide is a GLP-1 hormone analog that helps people eat less and reduce calorie intake by reducing hunger and increasing satiety, thereby inducing weight loss.
The STEP program (Therapeutic Efficacy of semaglutide in Obese Populations) is a Phase III clinical development program evaluating weekly subcutaneous (SC) semaglutide 2.4 mg for weight management in obese adults. The global Phase IIIa program includes four Phase IIIa trials enrolling approximately 4,500 overweight or obese adults.
Currently, Novo Nordisk has developed an injectable formulation (Ozempic) and an oral formulation (Rybelsus) for semaglutide:
- Ozempic (semaglutide, injection preparation): is a once-weekly subcutaneous injection preparation (0.5mg or 1mg), suitable for: (1) as an adjunct to dietary modification and exercise to improve glycemic control in adults with type 2 diabetes (2) For adults with type 2 diabetes who have cardiovascular disease (CVD), reduce the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal heart attack, non-fatal stroke).
Ozempic was first approved by the U.S. FDA in December 2017, and it has been marketed in many countries and regions around the world. The second indication of the drug was approved by the US FDA in January 2020. Data from the Cardiovascular Outcomes Trial (CVOT) SUSTAIN 6 showed that in patients with type 2 diabetes at high cardiovascular (CV) risk, when combined with standard care , Ozempic reduced the risk of the MACE composite endpoint by a statistically significant 26% compared to placebo.
- Rybelsus (semaglutide, oral tablet): is a once-daily oral formulation containing an absorption-promoting excipient, SNAC, indicated for: as a dietary modification and exercise and adjunctive drug for the improvement of adults with type 2 diabetes The patient’s glycemic control. Rybelsus is the world’s first and only oral GLP-1 receptor agonist, which is administered once a day in two therapeutic doses: 7mg and 14mg.
In the U.S., the label for Rybelsus was updated in January 2020 to include additional information on PIONEER 6 CVOT demonstrating CV safety in patients with type 2 diabetes at high CV risk, with data showing that when combined with standard care, Rybelsus met the primary endpoint of non-inferiority for the composite MACE endpoint compared to placebo, demonstrating a CV safety profile. In the study, the proportion of patients who experienced at least one MACE was 3.8% in the Rybelsus group and 4.8% in the placebo group.
