Sat, Jul-27-24, 09:01
|
 |
Senior Member
Posts: 2,186
|
|
Plan: Atkins-ish (hypoglycemia)
Stats: 000/000/000
BF:
Progress: 50%
|
|
Now the UK is getting on the bandwagon of prescribing Wegovy to reduce heart risks:
Quote:
Novo Nordisk’s Wegovy weight loss drug wins UK approval for use as a heart treatment
The U.K.’s health regulator on Tuesday approved the use of Novo Nordisk’s Wegovy weight loss drug to reduce the risk of overweight and obese adults suffering from serious heart problems or strokes.
The new approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) makes the Danish pharmaceutical giant’s GLP-1 obesity drug the first in the country to be prescribed for prevention of cardiovascular events in people with obesity.
It follows similar label expansion by the U.S. Food and Drug Administration in March.
Shares of Novo Nordisk were up after the announcement, trading 1.46% higher by 4:10 p.m. London time after pushing higher for much of the session.
The MHRA’s deputy director of innovative medicines, Shirley Hopper, said the decision marked an “important step forward” in combatting the effects of obesity.
“We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this medicine have been met,” Hopper said in a statement.
“This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity,” she added.
Novo Nordisk’s blockbuster Wegovy injection was already approved in the U.K. for treatment of obesity and for weight management, to be used alongside diet, physical activity and behavioral support.
However, the new approval marks a major coup for the company as it seeks to move beyond Wegovy’s image as a “vanity drug” and fend off growing competition.
Results of a closely watched late-stage “SELECT” trial, published in August 2023, pointed to the drug’s efficacy in reducing major cardiovascular events by 20% compared with a placebo.
|
https://www.cnbc.com/2024/07/23/nov...eart-risks.html
Meanwhile....
Quote:
GLP-1s Are Growing In Popularity For Weight Loss But Losing Steam Among People With Diabetes, Study Suggests
Topline
The use of GLP-1 medications like semaglutide for weight loss has increased twofold over the past decade, but declined in use among those with type 2 diabetes, according to a new study, and the researchers warn the resulting and ongoing drug shortage may limit the access people with diabetes have to the drugs.
Key Facts
Researchers from Cedars-Sinai Medical Center examined 1 million first-time GLP-1 prescriptions in the U.S. between 2011 and 2023 and separated patients by those who took GLP-1s for type 2 diabetes, and those who didn’t have diabetes but took them for obesity or obesity-related health conditions like high blood pressure and heart disease.
The amount of new patients prescribed GLP-1s for diabetes decreased by almost 10% between 2011 and 2023, while those who were prescribed the drugs for obesity or other obesity-related conditions more than doubled during the same time period, particularly since 2020, according to the study published Monday in the Annals of Internal Medicine.
Novo Nordisk’s semaglutide—the generic name for Ozempic, Wegovy and Rybelsus—was the most prescribed GLP-1 in 2023, making up over 88% of all new prescriptions.
GLP-1s are medications designed to manage type 2 diabetes, heart disease and obesity by lowering blood sugar and A1C, interacting with the hunger part of the brain to suppress the appetite and slowing down the process of food emptying from the stomach, causing patients to feel full longer.
The researchers warned the medications’ growing popularity among those with obesity could be exacerbating a nationwide drug shortage, and also raises concerns about “the need to ensure that patients with diabetes still have access to these treatments,” Dr. Yee Hui Yeo, the study’s co-first author and a clinical fellow in the Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai, said in a statement.
What Glp-1s Have Been Approved For Weight Loss?
There are seven approved GLP-1 drugs in the U.S. There’s also a similar class of medications called dual GLP-1 and GIP receptor agonists, and tirzepatide (the generic name for Mounjaro and Zepbound) is the only drug available in the U.S. from this group. However, only semaglutide, liraglutide—the generic name for Saxenda and Victoza—and tirzepatide have been approved by the Food and Drug Administration for weight management. Saxenda was the first to be approved in 2014, followed by Wegovy in 2020 and Zepbound in 2023.
Is There Still A Glp-1 Drug Shortage?
Yes, several GLP-1s have been in short supply for months, though some appear to be back in stock. The three lowest doses of Wegovy are still in a shortage with no expected date of recovery, while all doses of Ozempic are available, according to the FDA’s database. Two doses of both Mounjaro and Zepbound are in a shortage, though the FDA reports availability will improve after July. Doses of Saxenda and Victoza are also in short supply. The FDA blames increasing demand as the reason for the shortages. The shortages aren’t just affecting the U.S.: The European Medicines Agency warned the GLP-1 drug shortage is a “major public health concern” that probably won’t be resolved in 2024. People with diabetes have had a hard time getting ahold of their medications because of the shortages, with some rationing their drugs to cope with the lack of supply, NPR reported.
Key Background
Adverse side effects may also be causing a decline in GLP-1 use among people with type 2 diabetes. Metformin is considered the go-to drug for glucose management in people with type 2 diabetes, but many patients take second-line drugs—type 2 diabetes drugs that aren’t insulin—like GLP-1s to assist with treatment, according to a study by Northwestern Medicine. Almost 40% of patients taking second-line diabetes drugs stop treatment, but this number is even higher (50%) among those taking GLP-1s. The researchers believe this may be due to gastrointestinal side effects—like vomiting, nausea and diarrhea—associated with GLP-1s. Other than side effects, the high cost of the drugs is also a leading cause of discontinuation, according to a separate study by the American Diabetes Association.
Big Number
$100 billion. That’s how much the weight loss drug industry could be worth by 2030, analysts estimate, though some believe this is a lowball estimate.
Surprising Fact
The Cedars-Sinai researchers also found the percentage of people who were prescribed GLP-1s who didn’t meet the FDA requirements for the drugs increased from 0.21% in 2019 to 0.37% in 2023. These are people who are being prescribed the drugs off-label even though they don’t have diabetes, obesity, heart disease or any other related health condition. Although a slight increase, this could be tied to the growing popularity of people who aren’t obese using Wegovy and other GLP-1s for weight loss. Using GLP-1s for weight loss without meeting the FDA requirements is “abuse,” and these people are “far more likely to develop the serious side effects,” Dr. Nancy Rahnama, a Beverly Hills-based internal and bariatric medicine specialist with her own private practice, told local newspaper the Beverly Hills Courier.
|
https://www.forbes.com/sites/ariann...study-suggests/
|
|
Threaded Mode