Novo’s Semaglutide for Heart Failure; Biocon Leads India’s Generic GLP-1 Charge; I’m a Doctor on Ozempic; Cost-Effectiveness of Semaglutide Versus Endoscopic Sleeve
Biocon Ltd. is leading India’s push to weight loss medications as patents lapse, unleashing generic supply for the global weight-loss market, from Bloomberg.
STAT News reports European regulators ‘…have found no evidence that GLP-1 drugs like Ozempic and Wegovy cause suicidal thoughts or actions.’
‘I’m a doctor on Ozempic – it’s effective under one condition…’ says President and CEO of Philadelphia College of Osteopathic Medicine, Jay Feldstein, DO in a deeply personal Newsweek article.
The New England Journal of Medicine published on the positive impact of Novo Nordisk’s semaglutide drug on people with obesity-related heart failure and type 2 diabetes.
The New York Times reports How Ozempic Turned a 1970s Hit Into an Inescapable Jingle.
Dr. Chris Thompson, writes in JAMA Network Open on the cost-effectiveness viability of semaglutide compared with endoscopic sleeve gastroplasty [ESG].
NEWS
Biocon Ltd. is leading India’s push to weight loss medications as patents lapse, unleashing a wave of generic supply for the global weight-loss market, from Bloomberg.
Novo Nordisk’s liraglutide, sold as Saxenda, is the first to lose patent protection.
Whilst not as effective as Ozempic or Mounjaro, the generic versions are just the beginning for drugmakers like Biocon.
CEO Siddharth Mittal said ‘…My leadership team and organization is ensuring that we do not give up the lead position we have now…’ and is closely followed by sector giants Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and Cipla, who are also developing their anti-obesity drugs.
STAT News reports European regulators ‘…have found no evidence that GLP-1 drugs like Ozempic and Wegovy cause suicidal thoughts or actions.’
The European Medicines Agency review followed anecdotal reports of patients experiencing thoughts of self-harm while on liraglutide and semaglutide, through analysis of medical records, clinical trials, post-marketing surveillance data, and other studies.
The announcement echoed the findings of a review by the U.S. Food and Drug Administration earlier this year.
OPINION
‘I’m a doctor on Ozempic – it’s effective under one condition…’ says President and CEO of Philadelphia College of Osteopathic Medicine, Jay Feldstein, DO in a deeply personal Newsweek article.
Dr. Feldstein states ‘…I struggle with my weight. As a physician, I understand the science of gaining and losing pounds. I speak often about culinary medicine.’
He adds ‘…even with knowledge and resources, I have lost and regained the same 25 pounds for nearly 30 years.’
Rightly so, the physician believes ‘…we ought to focus on the bigger picture – obesity is a widespread and deadly chronic disease, and we have now found an effective treatment.’
More broadly, we must not ‘…distract from important questions like cost, supply, and equitable access.’
These drugs are truly game-changers, but not just because of the weight loss achieved; so much more in my opinion that the narrative on obesity as a chronic disease is finally changing, in that we may truly have ‘…profound implications for millions of patients and may reshape the healthcare system.’
DATA
The New England Journal of Medicine published on the positive impact of Novo Nordisk’s semaglutide drug on people with obesity-related heart failure and type 2 diabetes.
From over 600 subjects, at 108 sites in 16 countries in Asia, Europe, and North and South America, those on the GLP-1 drrug had ‘…larger reductions in heart failure-related symptoms and physical limitations and greater weight loss than placebo at 1 year…’ in addition to improved quality of life and social function.
Total weight loss was almost 10% at one year in the semaglutide group, and 3.4% in the placebo group.
In this sicker group of patients, the rate of serious adverse events were reported in 55 participants (17.7%) in the semaglutide group, and 88 (28.8%) in the placebo group.
The study also ascribes that the moderate 10% total weight loss is not the defining factor to impact clinical disease, with mechanisms extending beyond weight loss.
This was mirrored by Dr. Mikhail Kosiborod, lead investigator and vice president of research at Saint Luke’s Health System who said this ‘…strongly implies that weight loss is not the only mechanism of benefit here, otherwise you would have expected less weight loss, less heart failure benefit. But that’s not what we’re seeing here.’
The study was presented at the American College of Cardiology meeting in Atlanta last week.
Anuradha Lala-Trindade, an advanced heart failure and transplant cardiologist at Mount Sinai in New York who was not involved in the study but advises Novo Nordisk added ‘…Now we have actual medications that confer clinical benefit.’
An additional publication in The Lancet pooled the results of two heart failure trials together; one that was published this week, and a past trial on patients with obesity-related heart failure, but without type 2 diabetes.
Their outcome, based upon over 1100 subjects, reiterated that ‘…semaglutide was superior to placebo in improving heart failure-related symptoms and physical limitations, and reducing bodyweight in participants with obesity-related heart failure with preserved ejection fraction.’
Keep a watch out for the next FDA approval on the use of semaglutide for patients with heart failure.
We rightly need to go beyond weight loss as a metric of success, and focus upon treatment of chronic diseases such as heart failure.
Dr. Chris Thompson, a well-known GI physician in Boston, writes in JAMA Network Open with colleagues, on the cost-effectiveness viability of semaglutide compared with endoscopic sleeve gastroplasty (ESG) over 5 years for individuals with class II obesity.
He states ‘…ESG is an incisionless, per-oral, minimally invasive endoscopic procedure that applies full-thickness sutures along the greater curvature of the stomach, from the inside, to reduce gastric capacity and alter gastric motility.’
The approach is much less well adopted than bariatric surgery that encompasses gastric sleeve or gastric bypass.
A comparison of the drug versus an endoscopic treatment was based upon a cost of $13,618 per year for semaglutide, versus $16,360 for ESG.
At year one, ESG was not cost-effective compared with semaglutide, but when the time horizon was extended to 2 years, ESG became cost saving and dominated the semaglutide strategy.
Importantly, the authors suggest the ‘…annual price of semaglutide must decrease by more than 3-fold to achieve nondominance with ESG.’
I am supportive of this study, though have some mindful commentary; the percentage total weight loss [%TWL] achieved by ESG is 12-20% which is firmly in the ball park for GLP-1s; whereas the %TWL is 25-30% for lap surgical sleeve gastrectomy.
In 2022, from a total of 280K bariatric procedures in the US, 160K [57%] were lap sleeve, 62K [22%] were lap bypass, and only 4,600 [1.6%] were ESG.
For me as a clinician, ESG is not viable in terms of its access or impact, and the greater focus needs to be upon expansion of access to bariatric surgery – namely gastric bypass and sleeve gastrectomy.
