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Lupin gets U.S. FDA nod for two generic diabetes drugs
Lupin gets U.S. FDA nod for two generic diabetes drugs

The Hindu

time5 days ago

  • Business
  • The Hindu

Lupin gets U.S. FDA nod for two generic diabetes drugs

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials. Both the products will be manufactured at the company's injectable facility in Nagpur, Lupin said. Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk's Victoza injection and had an estimated annual sale of $458 million in the U.S, the company said citing IQVIA MAT May numbers. The drug is indicated to improve glycaemic control in adults and children, aged above 10 years, with type 2 diabetes mellitus. Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company's Glucagon for Injection, 1 mg/vial. It is indicated for treatment of severe hypoglycaemia in paediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. It had an estimated annual sale of $124 million in the U.S. Chief Scientific Officer Shahin Fesharaki said the two products are a meaningful enhancement to the company's portfolio.

India's Obesity Crisis Meets ‘Miracle Drugs' — Are We 'Flying Blind' Into Another Health Disaster?
India's Obesity Crisis Meets ‘Miracle Drugs' — Are We 'Flying Blind' Into Another Health Disaster?

Time of India

time15-07-2025

  • Health
  • Time of India

India's Obesity Crisis Meets ‘Miracle Drugs' — Are We 'Flying Blind' Into Another Health Disaster?

New Delhi: As India grapples with a staggering 254 million people living with overweight or obesity, the arrival of weight-loss drugs or weight-related drugs has ignited both hope—and alarm. At an exclusive Healthworld webinar, top Indian clinicians warned: this could be a transformative moment in chronic disease care , or it could spiral into unregulated chaos. The experts had one message in unison: GLP-1s are not to be used as cosmetics. They are clinical tools. And misuse could unleash a crisis. The webinar titled 'Weighing In: India's Medical Weight-loss Revolution,' the session brought together leading cardiologists, endocrinologists, and surgeons to examine to know if the new class of drugs are helping into major shift India's obesity or getting on to be a pandora's box. The leading doctors participating in the panel were Dr. Ashok Seth, Chairman, Fortis Escorts Heart Institute, Dr. Shashank Joshi, Consultant, Department of Diabetology and Endocrinology, Lilavati Hospital & Research Centre and Dr. Muffazal Lakdawala, Director, General Surgery & Minimal Access Surgical Sciences, Edge & Reliance Foundation Hospital. A few of the drugs in India that are used for weight-loss include Orlistat, Liraglutide (Victoza), Semaglutide (Wegovy and Rybelsus) and tirzepatide (Mounjaro). Among these, Orlistat is one of the early drugs that was specifically approved for obesity treatment, while the others are among the newly approved for weight loss treatment. Just as the hype grows, a Public Interest Litigation (PIL) has reached the Delhi High Court, warning against the aggressive marketing and uncontrolled sale of GLP-1 drugs in gyms and wellness clinics. As the drugs grow in popularity, they are increasingly being peddled without prescriptions, fuelling fears of another health disaster. 'These are prescription-only drugs,' warned Dr Shashank Joshi, leading endocrinologist from Lilavati Hospital. 'They are meant for high-risk patients with obesity and metabolic diseases—not for healthy people chasing cosmetic goals. Dispensing them without supervision is not just illegal—it's dangerous.' A New Era in Obesity Treatment—If Done Right Unlike the banned appetite suppressants of the past, GLP-1 receptor agonists come with robust evidence from global trials. The SELECT trial showed a 20 per cent reduction in major cardiovascular events in patients treated with semaglutide. 'Obesity is no longer about appearance. It's a chronic, systemic disease,' said Dr. Ashok Seth, Chairman, Fortis Escorts Heart Institute. 'For the first time, we have a pharmacological tool that reduces not just weight, but real, hard endpoints like heart attacks and strokes. That changes everything.' Dr. Muffazal Lakdawala, renowned bariatric surgeon, was blunt: 'India is sitting on a ticking obesity bomb. And if we let these drugs turn into gym-floor fads, we will be repeating the antibiotic misuse crisis.' He added, 'These are not shortcuts to six-packs. They are meant for carefully selected patients. I reject 90 per cent of surgical weight-loss requests for being inappropriate—now imagine how many unqualified people are chasing these drugs for the wrong reasons.' One of the most powerful takeaways from the panel was the push to reframe obesity not as a failure of will power but as a chronic, relapsing medical condition—with roots in genetics, environment, and biology. 'We must stop fat-shaming,' said Dr. Joshi. 'And we must stop using outdated tools like BMI alone. Indian bodies are metabolically different—what we call 'thin-fat'—lean on the outside but high in visceral fat and risk inside.' Experts informed that lifestyle change remains essential, but for many, especially those with BMI over 27 with comorbidities, GLP-1 drugs may be the difference between disease progression and reversal. The panel stressed that with power comes responsibility. India lacks a real-time pharmacovigilance system to monitor off-label use or adverse effects—unlike in the US or Europe. 'We are flying blind,' said Dr. Joshi. 'Without safeguards, this miracle will become a mess. Regulators must enforce prescription protocols and clamp down on black-market supply before it's too late.' Talking about the affordability vs access of these weight-loss drugs the experts informed that with semaglutide injections priced at ₹26,000/month, affordability remains a major hurdle. But doctors argued that the cost of untreated obesity—dialysis, bypass surgeries, stroke rehab—is far higher. Dr Lakdawala put it simply: 'We must think in terms of cost-effectiveness, not sticker price. And as generics enter the market, access can improve—but only if regulation keeps pace.' This Is Science, Not Vanity Across the board, experts made an urgent appeal to ditch the 'weight-loss drug' label. 'These are disease-modifying agents that can prevent diabetes, reverse fatty liver, and cut heart disease,' said Dr. Seth. 'Calling them cosmetic trivializes their life-saving potential.' Dr. Joshi added, 'Let's not rob the sick to serve the slim. Off-label demand abroad has already caused shortages. India must prioritize medical need, not market hype.' India stands at a crucial crossroads. With GLP-1 drugs offering a powerful tool to manage obesity, diabetes, and heart disease, the path forward must be one of caution, regulation, education, and equity, added experts. Summing it up well, Dr Joshi said, "We are in the best of times for chronic disease innovation. But we're also in the worst of times—if we let hype override science.'

Market to Surpass $120 Billion by 2034 - Increased Strategic Merger and Initiatives to Meet Rising Demand
Market to Surpass $120 Billion by 2034 - Increased Strategic Merger and Initiatives to Meet Rising Demand

Yahoo

time08-07-2025

  • Business
  • Yahoo

Market to Surpass $120 Billion by 2034 - Increased Strategic Merger and Initiatives to Meet Rising Demand

The anti-obesity drugs market, valued at USD 3.20 billion in 2024, is propelled by rising obesity prevalence worldwide, aiming for USD 120.32 billion by 2034 at 43.72% CAGR. Key drivers include FDA-approved drugs like Liraglutide, strategic mergers, regulatory support, and rising awareness. Top players include Novo Nordisk and Eli Lilly. Anti-Obesity Drugs Market Dublin, July 08, 2025 (GLOBE NEWSWIRE) -- The "Anti-Obesity Drugs Market Report and Forecast 2025-2034" report has been added to anti-obesity drugs market was valued at USD 3.20 Billion in 2024, driven by rising prevalence of obesity across the 8 major markets. The market is expected to grow at a CAGR of 43.72% during the forecast period of 2025-2034, with the values likely to reach USD 120.32 Billion by 2034. Anti-Obesity Drugs Market OverviewAnti-obesity drugs target different aspects of weight management such as appetite suppression, fat absorption, and metabolic enhancement. There are several anti-obesity drugs approved by the United States Food and Drug Administration (FDA) for long-term use, including Bupropion-naltrexone (Contrave), Liraglutide (Saxenda), Orlistat (Xenical, Alli), Phentermine-topiramate (Qsymia), and Semaglutide (Wegovy), among others. Some weight loss medications like semaglutide (Wegovy), liraglutide (Saxenda), and tirzepatide (Zepbound) can help in reducing body weight by 20%.The anti-obesity drugs market growth is driven by the rising prevalence of obesity worldwide, increasing awareness about the health risks associated with obesity, and growing partnerships in obesity-related research. Furthermore, the surge in drug approvals by health regulatory agencies and innovation in drug development are some of the factors that are expected to positively influence the market Drugs Market Growth Drivers Rising Prevalence of Obesity to Foster the Market Landscape SignificantlyThe market is driven by rising prevalence of obesity which makes an individual prone to various health complications such as diabetes, cardiovascular diseases, and certain cancers. According to the World Health Organization (WHO), in 2022, around 2.5 billion adults (18 years or older) were overweight, out of which around 890 million adults were living with obesity. This equates to about 43% of the adults being overweight which shows an increase from the 1990, when 25% of adults aged 18 years and above were overweight. In addition, as per the latest World Obesity Atlas 2023, it is expected that the number of individuals falling in the overweight and obesity category will reach 4 billion by 2035. This indicates that every 1 in 5 women and 1 in 7 men, will be living with obesity by Strategic Merger and Initiatives to Meet Rising Anti-Obesity Drugs Market DemandOne of the significant market trends is the rise in strategic merger and acquisition initiatives taken by the key market players to expand production capacities and support the development of novel drug pipelines. Recently, in January 2024, Roche completed the acquisition of Carmot Therapeutics Inc. dedicated in developing the therapeutics for the people living with metabolic diseases including obesity and diabetes. Further, rising investments aimed at introducing safer and more efficient anti-obesity drugs in the market are also anticipated to accelerate market growth. In January 2024, Adipo Therapeutics closed a USD 1.9 million seed financing gap to advance the treatment of Type 2 diabetes and obesity. Market Segmentation Based on Product Type is Anticipated to Witness Substantial GrowthBy drugs, the market is segmented into Semaglutide, Phentermine/Topiramate, Naltrexone/Bupropion, Liraglutide, Gelesis 100, Orlistat, Phentermine, Methamphetamine, and Tirzepatide. Each anti-obesity drug works on distinct mechanisms and shows different effects on weight management. Among the different anti-obesity drugs, the two anti-obesity drugs that have been approved for long-term usage are sibutramine and orlistat. However, they can even cause minor side-effects such as flatulence and Drugs Market Analysis by RegionBased on region, United States is the market is witnessing significant growth which can attributed to an advanced healthcare system offering access to various anti-obesity drugs to the huge patient population. With 78% of adults in the United States estimated to be overweight or obese by 2030, the rising prevalence of obesity in the region is poised to propel the market growth in the coming years. In addition, the increased funding, and investments to support the development of novel weight loss drugs is expected to augment the anti-obesity drugs market also holds a high market value, owing to the presence of leading market players in the region. Moreover, the dominance of the regional market is a result of the rising adoption of obesity treatment solutions and growing investments in obesity research and drug development. India is projected to witness substantial growth. It can be accredited to changing lifestyle of the people that can result in Drugs Market TrendsIncreased Focus on Combination TherapiesThere is a growing interest in combination therapies that target multiple pathways to induce weight loss. Such combinations can offer better efficacy as compared to conventional Patient AwarenessThere is an increased awareness and acceptance of obesity as a chronic disease requiring medical intervention, rather than just lifestyle changes. This shift is contributing to the rising anti-obesity drugs market SupportRegulatory agencies are providing transparent guidelines and support for the development and approval of anti-obesity drugs. This includes fast-track designations and approvals for drugs that exhibit significant benefits in clinical Use of GLP-1 Receptor AgonistsGlucagon-like peptide-1 (GLP-1) receptor agonists, originally developed for diabetes treatment, are increasingly preferred for obesity management due to their ability to induce weight loss. Key Attributes: Report Attribute Details No. of Pages 400 Forecast Period 2025 - 2034 Estimated Market Value (USD) in 2025 $3.2 Billion Forecasted Market Value (USD) by 2034 $120.32 Billion Compound Annual Growth Rate 43.7% Regions Covered Global Supplier Landscape GlaxoSmithKline PLC Pfizer Inc. Novo Nordisk A/S Rhythm Pharmaceuticals KVK Tech Inc. Currax Pharmaceuticals LLC CHEPLAPHARM Arzneimittel GmbH Vivus LLC Gelesis Holding Inc. Boehringer Ingelheim International GmbH Eli Lilly and Company Anti-Obesity Drugs Market SegmentationBreakup by Drug Type Semaglutide Phentermine/Topiramate Naltrexone/Bupropion Liraglutide Gelesis 100 Orlistat Phentermine Methamphetamine Tirzepatide Others Breakup by Drug Class Amphetamine GLP-1 Receptor Agonist Lipase Inhibitor Others Breakup by Mechanism of Action Centrally Acting Drugs Peripherally Acting Drugs Breakup by Prescription Type Prescription Drugs Over The Counter Drugs Breakup by Distribution Channel Hospital Pharmacies Drug Store & Retail Pharmacies Online Pharmacies Breakup by Region United States EU-4 and the United Kingdom Germany France Italy Spain United Kingdom Japan India For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Anti-Obesity Drugs Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Market to Surpass $120 Billion by 2034 - Increased Strategic Merger and Initiatives to Meet Rising Demand
Market to Surpass $120 Billion by 2034 - Increased Strategic Merger and Initiatives to Meet Rising Demand

Yahoo

time08-07-2025

  • Business
  • Yahoo

Market to Surpass $120 Billion by 2034 - Increased Strategic Merger and Initiatives to Meet Rising Demand

The anti-obesity drugs market, valued at USD 3.20 billion in 2024, is propelled by rising obesity prevalence worldwide, aiming for USD 120.32 billion by 2034 at 43.72% CAGR. Key drivers include FDA-approved drugs like Liraglutide, strategic mergers, regulatory support, and rising awareness. Top players include Novo Nordisk and Eli Lilly. Anti-Obesity Drugs Market Dublin, July 08, 2025 (GLOBE NEWSWIRE) -- The "Anti-Obesity Drugs Market Report and Forecast 2025-2034" report has been added to anti-obesity drugs market was valued at USD 3.20 Billion in 2024, driven by rising prevalence of obesity across the 8 major markets. The market is expected to grow at a CAGR of 43.72% during the forecast period of 2025-2034, with the values likely to reach USD 120.32 Billion by 2034. Anti-Obesity Drugs Market OverviewAnti-obesity drugs target different aspects of weight management such as appetite suppression, fat absorption, and metabolic enhancement. There are several anti-obesity drugs approved by the United States Food and Drug Administration (FDA) for long-term use, including Bupropion-naltrexone (Contrave), Liraglutide (Saxenda), Orlistat (Xenical, Alli), Phentermine-topiramate (Qsymia), and Semaglutide (Wegovy), among others. Some weight loss medications like semaglutide (Wegovy), liraglutide (Saxenda), and tirzepatide (Zepbound) can help in reducing body weight by 20%.The anti-obesity drugs market growth is driven by the rising prevalence of obesity worldwide, increasing awareness about the health risks associated with obesity, and growing partnerships in obesity-related research. Furthermore, the surge in drug approvals by health regulatory agencies and innovation in drug development are some of the factors that are expected to positively influence the market Drugs Market Growth Drivers Rising Prevalence of Obesity to Foster the Market Landscape SignificantlyThe market is driven by rising prevalence of obesity which makes an individual prone to various health complications such as diabetes, cardiovascular diseases, and certain cancers. According to the World Health Organization (WHO), in 2022, around 2.5 billion adults (18 years or older) were overweight, out of which around 890 million adults were living with obesity. This equates to about 43% of the adults being overweight which shows an increase from the 1990, when 25% of adults aged 18 years and above were overweight. In addition, as per the latest World Obesity Atlas 2023, it is expected that the number of individuals falling in the overweight and obesity category will reach 4 billion by 2035. This indicates that every 1 in 5 women and 1 in 7 men, will be living with obesity by Strategic Merger and Initiatives to Meet Rising Anti-Obesity Drugs Market DemandOne of the significant market trends is the rise in strategic merger and acquisition initiatives taken by the key market players to expand production capacities and support the development of novel drug pipelines. Recently, in January 2024, Roche completed the acquisition of Carmot Therapeutics Inc. dedicated in developing the therapeutics for the people living with metabolic diseases including obesity and diabetes. Further, rising investments aimed at introducing safer and more efficient anti-obesity drugs in the market are also anticipated to accelerate market growth. In January 2024, Adipo Therapeutics closed a USD 1.9 million seed financing gap to advance the treatment of Type 2 diabetes and obesity. Market Segmentation Based on Product Type is Anticipated to Witness Substantial GrowthBy drugs, the market is segmented into Semaglutide, Phentermine/Topiramate, Naltrexone/Bupropion, Liraglutide, Gelesis 100, Orlistat, Phentermine, Methamphetamine, and Tirzepatide. Each anti-obesity drug works on distinct mechanisms and shows different effects on weight management. Among the different anti-obesity drugs, the two anti-obesity drugs that have been approved for long-term usage are sibutramine and orlistat. However, they can even cause minor side-effects such as flatulence and Drugs Market Analysis by RegionBased on region, United States is the market is witnessing significant growth which can attributed to an advanced healthcare system offering access to various anti-obesity drugs to the huge patient population. With 78% of adults in the United States estimated to be overweight or obese by 2030, the rising prevalence of obesity in the region is poised to propel the market growth in the coming years. In addition, the increased funding, and investments to support the development of novel weight loss drugs is expected to augment the anti-obesity drugs market also holds a high market value, owing to the presence of leading market players in the region. Moreover, the dominance of the regional market is a result of the rising adoption of obesity treatment solutions and growing investments in obesity research and drug development. India is projected to witness substantial growth. It can be accredited to changing lifestyle of the people that can result in Drugs Market TrendsIncreased Focus on Combination TherapiesThere is a growing interest in combination therapies that target multiple pathways to induce weight loss. Such combinations can offer better efficacy as compared to conventional Patient AwarenessThere is an increased awareness and acceptance of obesity as a chronic disease requiring medical intervention, rather than just lifestyle changes. This shift is contributing to the rising anti-obesity drugs market SupportRegulatory agencies are providing transparent guidelines and support for the development and approval of anti-obesity drugs. This includes fast-track designations and approvals for drugs that exhibit significant benefits in clinical Use of GLP-1 Receptor AgonistsGlucagon-like peptide-1 (GLP-1) receptor agonists, originally developed for diabetes treatment, are increasingly preferred for obesity management due to their ability to induce weight loss. Key Attributes: Report Attribute Details No. of Pages 400 Forecast Period 2025 - 2034 Estimated Market Value (USD) in 2025 $3.2 Billion Forecasted Market Value (USD) by 2034 $120.32 Billion Compound Annual Growth Rate 43.7% Regions Covered Global Supplier Landscape GlaxoSmithKline PLC Pfizer Inc. Novo Nordisk A/S Rhythm Pharmaceuticals KVK Tech Inc. Currax Pharmaceuticals LLC CHEPLAPHARM Arzneimittel GmbH Vivus LLC Gelesis Holding Inc. Boehringer Ingelheim International GmbH Eli Lilly and Company Anti-Obesity Drugs Market SegmentationBreakup by Drug Type Semaglutide Phentermine/Topiramate Naltrexone/Bupropion Liraglutide Gelesis 100 Orlistat Phentermine Methamphetamine Tirzepatide Others Breakup by Drug Class Amphetamine GLP-1 Receptor Agonist Lipase Inhibitor Others Breakup by Mechanism of Action Centrally Acting Drugs Peripherally Acting Drugs Breakup by Prescription Type Prescription Drugs Over The Counter Drugs Breakup by Distribution Channel Hospital Pharmacies Drug Store & Retail Pharmacies Online Pharmacies Breakup by Region United States EU-4 and the United Kingdom Germany France Italy Spain United Kingdom Japan India For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Anti-Obesity Drugs Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Delhi HC directs DCGI to examine weight loss drug combinations, instructs to take expert consultation
Delhi HC directs DCGI to examine weight loss drug combinations, instructs to take expert consultation

India Gazette

time02-07-2025

  • Health
  • India Gazette

Delhi HC directs DCGI to examine weight loss drug combinations, instructs to take expert consultation

New Delhi [India], July 2 (ANI): The Delhi High Court has directed the Drug Controller General of India (DCGI) to examine and address issues raised in a petition challenging the approval and sale of certain weight loss drug combinations in India. The Court instructed the DCGI to consult medical experts, stakeholders, and drug manufacturers before arriving at any regulatory decision. The bench of Justice Devendra Kumar Upadhyay and Justice Tushar Rao Gedela acknowledged the issues raised and stressed the need for initial regulatory scrutiny. The petitioner has been permitted to submit an additional representation within two weeks, supplementing a previous one submitted in April. The Court further directed the DCGI to provide a well-reasoned decision within three months, considering expert advice and industry input. The proceedings arise from a Public Interest Litigation (PIL) seeking a ban on the sale of weight loss drugs that are still undergoing clinical trials internationally. The PIL specifically raised concern over India's approval of GLP-1 RA drugs--Semaglutide, Tirzepatide, and Liraglutide--for weight loss and cosmetic purposes without adequate India-specific trials, safety data, or regulatory checks. Originally developed for diabetes treatment, these drugs are now under global scrutiny for potentially severe side effects, including cancer risks, organ damage, and neurological complications, the plea stated. The plea also flags the aggressive, unregulated marketing of these drugs--especially to younger demographics--alongside the absence of post-market surveillance and transparency in approval processes. It argues that these regulatory lapses threaten the constitutional right to health and calls for immediate judicial oversight to avert a potential public health crisis. The plea was filed by Jitendra Chouksey, with Senior Advocate Diya Kapur leading the arguments, assisted by Advocate Rohit Kumar. (ANI)

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