Novo Nordisk Submits FDA Applications for Oral Semaglutide in Type 2 Diabetes and Cardiovascular Risk Reduction

VCBeat (WeChat ID: vcbeat) has learned that biopharmaceutical company Novo Nordisk recently submitted two applications to the U.S. Food and Drug Administration (FDA). One application seeks approval for oral semaglutide as an adjunct treatment to diet and exercise, for which the company utilized a Priority Review Voucher in hopes of receiving an FDA response within six months. The other application seeks approval for semaglutide to reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes; this application is subject to a standard 10-month review cycle.

Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist formulated with the absorption-enhancing excipient SNAC for once-daily oral administration. This medication promotes insulin secretion and suppresses glucagon secretion through a glucose concentration-dependent mechanism, significantly improving glycemic control in patients with type 2 diabetes while reducing the risks of hypoglycemia and major adverse cardiovascular events (MACE). Additionally, semaglutide reduces appetite, helping patients decrease their food intake and achieve weight loss.

It is reported that the global prevalence of diabetes stands at 6.6%, with the number of affected individuals reaching 366 million in 2011, representing an increase of nearly 30% compared to 2010. Among these cases, 90% are type 2 diabetes. The disease has become a global epidemic following cardiovascular diseases and cancer, and it is a leading cause of mortality and disability among adult patients.

At present, injectable insulin remains the mainstream treatment in the diabetes market; however, it is prone to causing hypoglycemia and weight gain in patients. Consequently, the development of oral insulin has been a key focus for major pharmaceutical companies. If semaglutide successfully obtains FDA approval for marketing, it will become the first oral GLP-1 receptor agonist, bringing substantial commercial returns to Novo Nordisk while also serving as a significant breakthrough for the vast population of patients with type 2 diabetes.

Semaglutide is the second GLP-1 receptor agonist antidiabetic drug launched by Novo Nordisk. As early as early December 2017, the subcutaneous injection Ozempic, developed by Novo Nordisk, was approved by the FDA for the treatment of type 2 diabetes. Like semaglutide, Ozempic is also a glucagon-like peptide-1 (GLP-1) receptor agonist. The two share similar active ingredients and efficacy, with the primary difference lying in their formulation forms.

Ozempic is hailed as the world’s premier GLP-1 agonist, with global sales reaching $2.7 billion in 2018. Pharmaceutical market research firm Evaluate Pharma projects that if semaglutide successfully launches, its sales will reach $2.35 billion by 2024.

Headquartered in Copenhagen, Denmark, Novo Nordisk is a biopharmaceutical company and a global leader in diabetes care, offering the most comprehensive portfolio of diabetes treatments. The company also focuses its research and development on chronic diseases such as hemophilia, growth hormone disorders, and obesity. With approximately 43,200 employees worldwide, Novo Nordisk provides products and services to more than 170 countries and regions.

(Compiled by Jiao Yanli)