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Many people with type 2 diabetes are not opting for injectables for fear of injections and the anticipation that injectables may limit their regular lifestyle. Semaglutide, a GLP-1 receptor analogue (GLP-1 RA), is one of the drug classes for the management of type 2 diabetes. But because it is available only in the form of injections, many patients are not using it, despite their doctor's recommendation. Because of which they struggle to get their blood glucose under control. Now, Novo Nordisk India has launched the world's first and only "peptide in a pill", oral semaglutide.
This is the first time semaglutide has been developed in an oral formulation. Indicated for glycaemic control in adults with type 2 diabetes, oral semaglutide is expected to be a gamechanger and a life changer in diabetes management.
According to Novo Nordisk, its oral semaglutide consists of GLP-1RA semaglutide and an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach like other peptides and enhances its absorption.
Oral semaglutide has undergone 10 rigorous Phase 3a clinical trials called PIONEER, across several countries including India. The trials include more than 10,000 patients of which more than 1,000 participants are from India. In addition to the unprecedented glycemic control, oral semaglutide demonstrated unsurpassed weight loss and consistent cardiovascular safety in clinical trials, the company said in a statement.
Novo Nordisk said it took them 15 years of continuous research, innovation, and development to make oral formulation of semaglutide into a reality. Due to this scientific breakthrough, it was honored with the Prix Galien Award in 2020, a prestigious award in the industry, for the best biotech innovation. The Drugs Controller General of India (DCGI) approved oral semaglutide in 2020.
Speaking at the launch, Vikrant Shrotriya, Corporate Vice President and Managing Director, Novo Nordisk India, said oral semaglutide has the potential to revolutionise the treatment of type 2 diabetes, given that millions of people do not achieve the targeted blood sugar levels with currently available oral antidiabetic medications.
"Its launch coincides with our hundred-year centenary of insulin discovery, that changed the life of people with diabetes needing insulin. Likewise, we believe, semaglutide in oral form will transform the management of diabetes demonstrating our dedication to advancing patient care through continued innovation," he added.
Glucagon-like peptide 1 (GLP-1) is a naturally occurring hormone and plays an important role in maintaining the normal level of glucose in the blood. Peptide and protein-based biological medicines are very effective, but because they are delivered as injectables, it becomes a barrier to optimal diabetes management, as many people prefer pills over injections, explained Dr. Shashank Joshi, Chair IDF Southeast Asia and Consultant Endocrinologist at Lilavati Hospital, Bhatia Hospital & Joshi Clinic, Mumbai.
He added, "Oral semaglutide represents a game changing innovation for both patients and HCPs in the field of diabetes, with the ease of oral administration combined with the benefits of a GLP-1 RA. It delivers unprecedented HbA1c control and unsurpassed weight loss, with a well-established safety profile consistent with the GLP-1 RA class3-8."
GLP-1RAs is not only effective in controlling blood sugar and body weight, but it has also been proven to be beneficial to the cardiovascular system, noted Dr. Vinay Kumar Bahl, Principal Director, Cardiology, Max Hospital, Delhi.
According to him, oral semaglutide has shown consistent cardiovascular safety with 21 per cent relative risk reduction in 3P MACE (non-fatal stroke, non-fatal heart attack, death due to cardiovascular diseases) and reduction in cardiometabolic risk factors.
Dr. V Mohan, Chairman, Dr. Mohan's Diabetes Specialities Centre, Chennai commented that availability of a drug which can improve both blood glucose and body weigh will be a boon for people with diabetes, especially during the pandemic, as they are at increased risk of COVID-19 related complications and mortality.
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