Novo Nordisk India Launches Oral Semaglutide for Diabetes

KOCHI:
Nisha (name changed) was diagnosed with type2 diabetes 6 years back. She started her treatment on oral anti-diabetic drugs (OADs), however, even after taking multiple medications daily, her diabetes was not under control. She was then advised by her treating physician to move to injections. However, fear of injections, the stigma associated with same and the anticipation that injectables may limit her regular lifestyle made Nisha not opt for injectables. She decided to continue on oral drugs, and to this day she still struggles to get her blood glucose under control. This is the story of 4 out 5 people living with type2 diabetes who prefer taking oral medications as compared to injections.

With a focus on innovating products that improve patients’ lives, Novo Nordisk India launched the world’s first and only “peptide in a pill”, oral semaglutide, a gamechanger in diabetes management.Semaglutide, a GLP-1 receptor analogue (GLP-1 RA) – one of the drug classes to treat diabetes, till now was available only in the form of injections. This is the first time a GLP-1 RA has been developed in an oral formulation.

Oral semaglutide is a co-formulation of GLP-1RA semaglutide with an absorption enhancer SNAC which protects semaglutide from undergoing degradation in the stomach like other peptides and enhances its absorption.Novo Nordisk invested 15 years of continuous research, innovation, and development to makeoral formulation of semaglutide into a reality. Due to this scientific breakthrough, it received the Prix Galien Award in 2020, a prestigious award in the industry, for the best biotech innovation.

It has undergone 10 rigorous Phase 3a clinical trials called PIONEER, across several countries including India. The completed and ongoing global trials with oral semaglutide includes more than 10,000 patients of which more than 1,000 participants are from India. 3-9 In addition to the unprecedented glycemic control, oral semaglutide demonstrated unsurpassed weight loss and consistent cardiovascular safety in clinical trials. Oral semaglutide has been approved by the Drugs Controller General of India (DCGI) in 2020. Oral semaglutide, which is indicated for glycaemic control in adults with type 2 diabetes, is expected to be a gamechanger and a life changer in diabetes management.  

Speaking at the launch, Vikrant Shrotriya, Corporate Vice President and Managing Director, Novo Nordisk India, said “We are extremely proud and elated to launch oral semaglutide in India. With a strong clinical profile, we believe, it 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.”
 
Dr. Shashank Joshi, Chair IDF Southeast Asiaand Consultant Endocrinologist at LilavatiHospital, Bhatia Hospital& Joshi Clinic, Mumbai said, “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 typically very effective, their only drawback being delivered as injectables. This can be a barrier to optimal diabetes management, as many people prefer pills over injections. 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 class 3-8 .”

Dr. Vinay Kumar Bahl, Principal Director, Cardiology, Max Hospital, Delhi said, “When diabetes is undetected and inadequately treated, patients are at higher risk of serious and life-threatening complications, such as heart attack, stroke, kidney failure, blindness, and lower-limb amputation. These complications result in reduced quality of life and impose higher healthcare costs. 10 The actions of GLP-1RAs go beyond their effects on blood sugar and body weight, also proven to be beneficial to the cardiovascular system. 11 Oral semaglutide has shown consistent cardiovascular safety (21% relative risk reduction in 3P MACE (non-fatal stroke, non-fatal heart attack, death due to cardiovascular diseases), (p-<0.05, for non-inferiority)) and reduction in cardiometabolic risk factors 7 “.

Dr. V Mohan, Chairman, Dr. Mohan’s Diabetes Specialities Centre, Chennai said, “People with diabetes and obesity are at increased risk of COVID-19 related complications and mortality. Availability of a drug which can improve both blood glucose and body weight, will be like hitting two targets with one arrow. Having such a unique molecule will be a boon for people with diabetes, especially during the pandemic.”

Globally, over 90% of people with diabetes have type 2 diabetes. 12 The rise in the number of people with type 2 diabetes is driven by a complex interplay of socio-economic, demographic, environmental, and genetic factors. Key contributors include urbanization, an aging population, decreasing levels of physical activity, and increasing prevalence of overweight and obesity. Currently, in India 1 in 12 adults (20-79 years) are living with diabetes. 12 On an average, 50% of people with type 2 diabetes (T2D) taking three or more oral anti-diabetes drugs (OADs) do not achieve target blood sugar levels. 13 Moreover, 77% fail to achieve glycaemic goals 14 while majority struggle with a high average HbA1c of 8.6% 13 uncontrolled blood sugar, excess weight, and increased cardiovascular risk further contribute to premature death and diabetes-related complication. 12,15 Early detection and treatment are the need of the hour in effectively managing the increasing diabetes population and further reducing co- morbidities.