Novo Nordisk Submits Application to FDA for Once-Weekly Ozempic (Semaglutide) 2.0 mg for Intensified Treatment of Type 2 Diabetes

January 25, 2021 /BioValleyBIOON/ -- Novo Nordisk recently announced that it has submitted to the U.S. Food and Drug Administration (FDA) submitted a label extension application to introduce a new 2.0 mg dose into the existing marketing authorization for the glucose-lowering medicine Ozempic (semaglutide, subcutaneous formulation, once weekly). On December 29, 2020, Novo Nordisk had already submitted the label extension application to the European Medicines Agency (EMA).

Ozempic is a once-weekly glucagon-like peptide-1 (GLP-1) analog. This medication is a subcutaneous injection formulation, currently approved in the United States at doses of 0.5 mg and 1.0 mg, indicated for: (1) as an adjunct to diet and exercise to improve type 2DiabetesBlood glucose control in adult patients; (2) for type 2 diabetes with cardiovascular disease (CVD)DiabetesIn adult patients, to reduce the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke).

This application for label expansion is based on the results of the SUSTAIN FORTE trial, which enrolled 961 patients with type 2 diabetes requiring intensified treatment.DiabetesPatients. Data showed that at week 40 of treatment, the 2.0 mg dose group demonstrated a statistically significant greater reduction in glycated hemoglobin (HbA1c) levels compared with the 1.0 mg dose group. Throughout the trial, both doses of semaglutide appeared to be safe and well tolerated. The most common adverse events were gastrointestinal in nature, mostly mild to moderate in severity, resolved over time, and were consistent with the GLP-1 receptor agonist class. Gastrointestinal adverse events associated with the 2.0 mg dose of semaglutide were similar to those observed with the 1.0 mg dose.

Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer at Novo Nordisk, stated: “We are pleased toFDAExcited to submit the 2.0 mg dose of semaglutide. In the SUSTAIN program, the majority of patients achieved the treatment goal of glycated hemoglobin (HbA1c) levels below 7%. However, some patients required intensified therapy. The use of the 2.0 mg dose will enable more patients with type 2Diabetes"The patient can achieve the treatment goal."

Semaglutide (Chinese generic name: semaglutide) is a human glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner, significantly improving blood glucose levels in patients with type 2 diabetes with a low risk of hypoglycemia.

Furthermore, semaglutide can also induce by reducing appetite and decreasing food intake,Weight Loss. In addition, semaglutide can significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.

Currently, Novo Nordisk has developed an injectable formulation (Ozempic) and an oral formulation (Rybelsus) for semaglutide:

——Ozempic (semaglutide, injection): is a once-weekly subcutaneous injection formulation (0.5 mg or 1 mg) indicated for: (1) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; (2) to reduce the risk of major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD).

Ozempic was first approved by the U.S. FDA in December 2017 and is currently marketed in many countries and regions worldwide. The drug’s second indication was approved by the U.S.FDAApproval, based on data from the cardiovascular outcomes trial (CVOT) SUSTAIN 6, shows that in patients with type 2 diabetes at high cardiovascular (CV) risk, Ozempic, when added to standard care, significantly reduced the risk of the composite MACE endpoint by 26% compared to placebo.

——Rybelsus (semaglutide, oral tablets):It is a once-daily oral formulation containing the absorption-enhancing excipient SNAC. The medication is indicated for: improving glycemic control in adult patients with type 2 diabetes, as an adjunct to diet and exercise. Rybelsus is the world’s first and only oral GLP-1 receptor agonist, administered once daily, with two therapeutic doses: 7 mg and 14 mg.

In the United States, the Rybelsus label was updated in January 2020 to include additional information from the PIONEER 6 cardiovascular outcomes trial (CVOT), which demonstrated cardiovascular (CV) safety. Conducted in patients with type 2 diabetes at high CV risk, the trial showed that Rybelsus, when added to standard care, met its primary endpoint of non-inferiority for the composite major adverse cardiovascular events (MACE) endpoint compared with placebo, thereby establishing CV safety. 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.

Currently, Novo Nordisk is also investigating a once-weekly 2.4 mg subcutaneous injection formulation of semaglutide as a treatment for obesity in adults. Semaglutide helps people eat less and reduce caloric intake by reducing hunger and increasing satiety, thereby inducingWeight Loss。

In December 2020, Novo Nordisk submitted a New Drug Application (NDA) for the 2.4 mg subcutaneous formulation of semaglutide to the U.S. FDA and the European EMA. This medication is a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated for long-term weight management. Notably, Novo Nordisk also submitted toFDASubmitted a Priority Review Voucher (PRV) to expedite the NDA review, which shortens the NDA review cycle from the standard 10 months to 6 months.

The indication applied for the 2.4 mg subcutaneous injection formulation of semaglutide is: as an adjunct to a reduced-calorie diet and increased physical activity, for the treatment of adult patients with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity.

Alzheimer's Disease - AD (Image source: tecake.in)

Furthermore, in December 2020, Novo Nordisk announced a plan to initiate Phase 3 clinical development to evaluate 14 mg oral semaglutide for the treatment of Alzheimer’s disease (AD). The 14 mg oral formulation of semaglutide is a once-daily oral version of the long-acting GLP-1 analog semaglutide. This decision was made following an assessment of GLP-1 data from preclinical models, real-world evidence studies, post hoc analyses of large cardiovascular outcome trials, and discussions with regulatory authorities.

Novo Nordisk Plans to Launch a Pivotal Phase 3a Clinical Program Enrolling Approximately 3,700 Patients with Early Alzheimer’s Disease. The program is scheduled to commence in the first half of 2021 and will evaluate the efficacy and safety of once-daily oral semaglutide versus placebo. In this trial, the expected main treatment period is approximately two years. (Bioon.com)

Original source: Novo Nordisk files for regulatoryapproval in the US of once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes