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The Hindu
24-07-2025
- 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.
Health Line
07-07-2025
- Health
- Health Line
Ozempic-Like Drug Liraglutide Slashes Migraine Days In Half, Study Finds
An Ozempic-like drug prescribed for diabetes has been found to reduce the frequency of debilitating migraine. Researchers say liraglutide might help migraine frequency and severity by reducing intracranial pressure. While promising, it's too soon to say whether liraglutide will become a migraine treatment. For millions of people with migraine, finding effective relief can be a frustrating journey marked by trial and error with various therapies. Hope may be on the horizon, however, according to a new pilot study published on June 17 in Headache: The Journal of Head and Face Pain. This discovery may lead to a novel treatment approach that targets underlying brain pressure mechanisms rather than just managing symptoms. The research suggests that liraglutide, a drug originally developed for diabetes (Victoza) and weight management (Saxenda), may significantly reduce the frequency of debilitating migraine. Intriguingly, this benefit appears to come independently of weight loss. Liraglutide reduces migraine frequency, severity The study authors note that migraine is a widespread neurological disorder affecting about 14.7% of the global population, often causing severe disability and impacting quality of life. However, while many treatments exist, a significant number of people continue to experience frequent attacks that don't respond to medication. This new study aimed to explore whether liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), could be an effective add-on therapy for people with high-frequency or chronic migraine who haven't responded to at least two conventional preventive treatments. The study took place in Naples, Italy, between January and July 2024. Researchers enrolled 31 adults with obesity with a body mass index (BMI) greater than 30 experiencing high-frequency episodic or chronic migraine (at least eight headache days per month). The subjects were also unresponsive to at least two preventive therapies, including standard care and anti-CGRP (calcitonin gene-related peptide) monoclonal antibodies. Those with clinical signs suggestive of idiopathic intracranial hypertension, such as papilledema or sixth nerve palsy, were excluded to focus on migraine without overt intracranial hypertension. Participants received daily subcutaneous injections of liraglutide, starting at 0.6 milligrams in the first week and increasing to 1.2 mg thereafter, while continuing their existing preventive treatments. Over 12 weeks, patients maintained headache diaries to record monthly headache days (MHDs) and completed the Migraine Disability Assessment (MIDAS) to evaluate migraine-related disability. BMI was measured at baseline and after 12 weeks to assess weight changes. After 12 weeks, the mean monthly headache days decreased from 19.8 to 10.7, an average reduction of 9.1 days — a statistically significant and clinically meaningful improvement. Nearly half of the participants (48%) experienced at least a 50% reduction in headache frequency, and 23% achieved a 75% or greater reduction. One person reported complete resolution of headaches. The MIDAS score, reflecting migraine-related disability, also dropped significantly from 60.4 to 28.6, indicating substantial improvements in daily functioning. BMI showed only a slight, non-significant reduction from 34.0 to 33.9. Statistical analysis confirmed that the decrease in headache frequency was independent of weight loss. Furthermore, age, sex, and concurrent medications did not influence the treatment response, suggesting liraglutide's migraine benefits are robust across these variables. Adverse events were mild and primarily gastrointestinal, such as nausea and constipation, occurring in 42% of participants. Importantly, no patients discontinued treatment due to side effects, and these symptoms resolved spontaneously. These findings offer preliminary clinical evidence that liraglutide can effectively reduce migraine frequency and disability in patients with obesity and refractory migraine, potentially through mechanisms related to intracranial pressure regulation and CGRP modulation rather than weight loss alone. This represents a novel therapeutic avenue distinct from current migraine preventives that largely focus on blocking CGRP's effects rather than preventing its release. While promising, the study did have limitations, including its open-label design, small sample size, lack of a control group, and relatively short follow-up. How liraglutide could help treat migraine The rationale behind this research stemmed from emerging evidence linking increased intracranial pressure (ICP) to migraine mechanisms. Chronic migraine and idiopathic intracranial hypertension without papilledema (IIHWOP) — a condition characterized by raised ICP without the typical eye swelling — share many clinical features and risk factors, such as obesity and female sex. Both conditions also show elevated levels of CGRP, a molecule known to play a key role in migraine pain pathways. Notably, common migraine preventives like topiramate reduce ICP, suggesting that controlling ICP might be an effective migraine treatment strategy. GLP-1RAs, including liraglutide, have been shown in animal models to reduce ICP by inhibiting the activity in the choroid plexus of an enzyme called the sodium-potassium pump. The choroid plexus is the brain region responsible for cerebrospinal fluid secretion. This mechanism reduces fluid buildup and pressure inside the skull. Additionally, these drugs have been demonstrated to decrease CGRP expression and central nervous system sensitization related to migraine. These promising preclinical findings were what led the researchers to test liraglutide's effects in a clinical migraine population. However, Peter Soh, MD, MPH, medical director at Soh Headache Center, LLC, who did not take part in the study, clarified that we don't yet know exactly how GLP-1RAs might reduce migraine frequency. '[I]n the population studied, several important variables — such as intracranial pressure — were not measured,' Soh told Healthline. 'Without further data, it's a little early to suggest a mechanism of action in this specific context,' he noted. Migraine treatment is personal Liraglutide could one day emerge as a valuable addition to the migraine treatment arsenal, particularly for those with difficult-to-treat migraine, offering hope for more effective and targeted relief beyond current options. However, liraglutide as a migraine treatment would have to first undergo more rigorous studies and clinical trials. Stewart Parnacott, PhD, CRNA, MBA, chief clinical officer at Ready Wellness and author of ' Too Young to Feel This Old,' said better research is still needed before doctors can recommend liraglutide as a migraine treatment. Parnacott wasn't involved in the study. 'We don't know how long the benefits last. We don't know if the same results happen with other GLP-1 drugs like semaglutide,' he told Healthline. 'And I'm not suggesting anyone start Saxenda just to treat their migraine, at least not yet.' If you're experiencing frequent migraine, effective interventions can be highly personal. Soh advised working with a healthcare professional or fellowship-trained headache specialist to optimize your treatment plan. This may include assessing your lifestyle habits and using a headache journal to track your response to therapies. 'Don't underestimate the impact of food, sleep, stress, hydration, hormones, and blood sugar swings,' Parnacott added. 'I've had patients cut their migraine days in half just by making small changes they didn't think would matter.'
Economic Times
02-07-2025
- Health
- Economic Times
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
Time of India
02-07-2025
- Health
- Time of India
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three months. The order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three months. However a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same grounds. The court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in question. Live Events Notably, Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making Ozempic. Victoza (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and obesity. Legal experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight management. The PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism. Fitness-tech entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it said. The drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
Daily Mail
30-06-2025
- Health
- Daily Mail
Newest shocking Ozempic side effect revealed... and users say their lives will never be the same
Blockbuster weight-loss shots may slash migraine days in half for millions of sufferers, a study suggests. Researchers in Italy gave 31 obese adults suffering from chronic or frequent migraines liraglutide, the active ingredient in weight-loss drugs Victoza and Saxenda. After three months, the participants' average number of migraine days dropped from 20 to 11. They also said their migraines were less disabling, meaning they were able to function better at work, school, social settings or around the house. While participants lost a small amount of weight, which has been shown to reduce migraine frequency by lowering inflammation and muscle strain, weight loss likely isn't what reduced migraines. The researchers believe liraglutide alleviates pressure from cerebrospinal fluid, the protective liquid that cushions the brain and spine. Dr Simone Braca, lead study author and neurologist at the University of Naples Federico II, suggests even slight buildups of cerebrospinal fluid can press on veins and nerves in the brain, which could trigger migraines. He suggested targeting cerebrospinal fluid levels could make migraines a thing of the past for the 47million Americans who suffer from them. The above chart shows the average number of migraine days before and after participants started liraglutide Dr Braca told ABC News: 'An increased pressure of the spinal fluid in the brain may be one of the mechanisms underlying migraine. 'And if we target this mechanism, this preliminary evidence suggests that it may be helpful for migraine.' Migraines are a severe form of headache that causes throbbing, pulsing pain, usually on one side of the head. These can last hours or days at a time and be triggered by stress, hormonal fluctuations, sleep issues, foods or drinks, smells, lights, noise and weather changes, among others. About one in seven Americans suffers migraines, but for women, that number is closer to one in five. This may be due to hormones like estrogen and menstrual cycles, as well as certain genes that increase susceptibility. Meanwhile, about one in eight Americans, or 40million, has reported taking a GLP-1 agonist like Victoza or Ozempic - which uses semaglutide as the active ingredient instead of liraglutide - at some point. The new study, published earlier this month in the journal Headache, looked at 31 obese adults who had at least eight headache days per month or were diagnosed with chronic migraine. Chronic migraine, which impacts about 4million Americans, is defined as having at least 15 headache days in a month. Study participants also had to have failed at least two standard migraine medications and have a body mass index (BMI) of at least 30, the threshold for obesity. The vast majority, 26, were female, and the average participant age was 45. They were given a 0.6 milligram dose of liraglutide every day for one week and then a 1.2 milligram dose every day for the remainder of the four weeks. All participants were asked to stay on their current migraine drugs if they took them. Using the patients' self-recorded symptom 'diaries,' the researchers found 15 patients had at least a 50 percent reduction in migraine frequency Seven participants (23 percent) saw their migraines drop by 75 percent, and one patient had no headaches at all after the study. On average, migraine days decreased from 20 to 11, a 42 percent difference. The team also measured each patient's Migraine Disability Assessment Score (MIDAS), which defines how much their migraines can disable them and make them less functional at work, school or home on a given day. A higher score is associated with greater disability. The researchers found MIDAS scores decreased from 60 to 29 on average, a 52 percent difference. Participants on average lost a small amount of weight, but it was not statistically significant. About 42 percent of participants (13) had mild side effects including nausea and constipation, but all of them stayed on the medication. There were several limitations to the study, such as the small sample size and the lack of data on glucose or A1C levels, which are linked to diabetes. The team wrote: 'Future studies, with extended follow-up durations, and higher dose evaluations, are necessary to better understand the long-term tolerability and effectiveness of liraglutide in migraine prevention.'
