Novo Nordisk Submits NDA for Oral Semaglutide with Triple Benefits: Glycemic Control, Weight Loss, and Cardiovascular Risk Reduction
Mar 24, 2019 09:39
CST Updated
09:39
Novo Nordisk
Insulin Developer and Manufacturer
FDA
U.S. Food and Drug Administration
March 24, 2019 /BioonBIOON/ --DiabetesPharmaceutical giant Novo Nordisk recently announced to the U.S. Food and Drug Administration (FDA) submitted two New Drug Applications (NDAs) for oral semaglutide and one Supplemental New Drug Application (sNDA) for once-weekly Ozempic (semaglutide).
One of the NDAs seeks approval for oral semaglutide for type 2DiabetesTreatment of Adult Patients. Novo Nordisk has submitted a Priority Review Voucher (PRV) to accelerate the review of this NDA, reducing the review time from the standard 10 months to 6 months. The submission of this NDA is based on data from the PIONEER clinical program, which includes 10 clinical studies and enrolled a total of 9,543 patients with type 2 diabetes.DiabetesPatients. Data from this program demonstrated that oral semaglutide resulted in greater reductions in blood glucose levels compared with sitagliptin (a DPP-4 inhibitor), empagliflozin (an SGLT-2 inhibitor), liraglutide (a GLP-1 analogue), and placebo. Furthermore, oral semaglutide was associated with greater mean weight loss compared with most active comparators. In this program, oral semaglutide exhibited a safe and well-tolerated profile, with nausea being the most common adverse event.
The Second NDA: Application for Approval of Oral Semaglutide for Type 2 DiabetesDiabetesIndication for reducing cardiovascular (CV) risk in adult patients. The review timeline for this NDA is the standard 10-month review period from the date of submission.
Another sNDA seeks approval for Ozempic to reduce cardiovascular risk in adult patients with type 2 diabetes. The review timeline for this sNDA is the standard 10 months from the date of submission.
Application for the indication of oral semaglutide and Ozempic to reduce cardiovascular (CV) risk, based on the results of two cardiovascular outcomes trials (CVOTs). These studies were conducted in adult patients with type 2 diabetes at high risk for cardiovascular events, evaluating the impact on cardiovascular event risk when adding semaglutide or placebo to standard care. Data from the PIONEER 6 study showed that, when combined with standard care, oral semaglutide reduced cardiovascular risk by 80% compared with placebo. Data from the SUSTAIN 6 study showed that, when combined with standard care, Ozempic reduced the risk of the composite endpoint of major adverse cardiovascular events (MACE) by 26% compared with placebo.
Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer at Novo Nordisk, stated, “For many patients with type 2 diabetes, achieving glycemic control and managing cardiovascular risk remain a challenge. We are excited about the submission of the regulatory application for the first oral GLP-1 receptor agonist, as we believe that oral semaglutide has the potential to further improve the treatment of type 2 diabetes in adults.”
Semaglutide is a novel long-acting glucagon-like peptide-1 (GLP-1) analog that promotes insulin secretion and inhibits glucagon secretion in a glucose concentration-dependent manner, significantly improving glycemic control in patients with type 2 diabetes with a low risk of hypoglycemia. Additionally, semaglutide can induceWeight LossIn addition, semaglutide can significantly reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.
In early December 2017, the once-weekly subcutaneous injection formulation of semaglutide was approved in the United StatesFDAApproved for sale under the brand name Ozempic, this drug is hailed as the world’s best GLP-1 agonist, with global sales in 2024 projected to reach $4.411 billion, second only toEli LillyGLP-1 agonist Trulicity (expected 2024 sales of $4.622 billion).
Currently, Novo Nordisk is also developing an oral version of semaglutide, a once-daily tablet containing the absorption-enhancing excipient SNAC. EvaluatePharma, a pharmaceutical market research firm, predicts that as the world’s first oral GLP-1 receptor agonist, oral semaglutide holds strong commercial prospects, with projected sales reaching $1.994 billion in 2024. (Bioon.com)