Health
Weight-loss data positions Eli Lilly’s tirzepatide for 2023 obesity approval


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Eli Lilly says its incretin drug tirzepatide is on track for approval in obesity later this year, following release of Phase 3 results which solidify its weight-loss profile.
Lilly announced data from its SURMOUNT-2 study of tirzepatide in obese diabetics Thursday, with the study showing about 16% weight loss. That equates to more than 34 pounds over nearly 17 months, the company said.
Weight loss in this late-stage study was expected to fall below the 21% seen in the earlier SURMOUNT-1 study, which included similar subjects without diabetes. Following the trial, Lilly said it will complete an application to the Food and Drug Administration for fast-track approval of tirzepatide in obesity over the coming weeks. Regulatory approval is expected by year’s end.
“We believe addressing obesity could make an enormous difference in millions of people’s lives, significantly impact public health and reduce health care costs,” Lilly CEO David Ricks said during a Thursday afternoon call to review the company’s first-quarter results, released yesterday as well. “We are encouraged by this important next step in the journey to redefine obesity care.”
FDA awarded tirzepatide fast-track designation last fall which, in addition to a rolling submission, should help to expedite the review. However, Lilly isn’t taking chances. It’s using a priority review voucher (PRV), which shaves four months from the review time.
“While we think the FDA will act quickly with the fast-track designation, we want to remove any uncertainty,” explained Mike Mason, president of Lilly Diabetes, during the earnings call. “We will be using a PRV and expect that we’ll get approval as early as the end of this year.”
The company’s obesity filing in the EU is already complete and approval there is expected in the first half of next year.
Tirzepatide, approved to treat type 2 diabetes under the brand name Mounjaro and launched in Q2 2022, was also a highlight of the quarter. Mounjaro generated sales of $569 million, beating Wall Street’s consensus by $135 million. The drug’s access picture improved, with roughly 55% of scripts reimbursed in the quarter versus 40% in the last three months of 2022.
Mounjaro sales are forecast to hit $3.7 billion this year, increasing to $8.1 billion in 2024, according to an estimate by J.P. Morgan Chase. Meanwhile, the company’s total incretin franchise is projected to reach nearly $40 billion by the mid-2030s.
“With unprecedented demand for the GLP-1 category, we expect production capacity to be a key gating factor for sales growth,” JPM’s Chris Schott wrote in a note to investors Thursday.
To that end, the company’s new manufacturing facility in North Carolina, set to double capacity, is coming on-line later this year and should help in that regard. Intermittent shortages, compounded by widespread off-label use, have made Mounjaro and other drugs in the GLP-1 class – namely Novo Nordisk’s Ozempic – hard to get.
Lilly would not confirm whether tirzepatide will be marketed for weight loss in the U.S. under a different brand name, similar to the way Novo splits branding for Wegovy and Ozempic, intended for obesity and diabetes, respectively.
Some analysts think the company is leaning toward distinct branding. Asked about the pros and cons of each, Mason cited the two-brand scenario’s “access benefits” and the ability to have “an empty vessel” for the unique promotion of an obesity indication. Merging the two makes for a more efficient supply chain and manufacturing.
Due to unforeseen high product demand and short-term manufacturing issues, Novo faced supply constraints for Wegovy that disrupted its launch. The Danish company said earlier this year that all dosage strengths of Wegovy were back in stock, which allowed the resumption of commercial activity.
“There’s just a tremendous unmet need in the obesity market,” said Mason, adding, “We’re not surprised by Wegovy’s uptake after the resupply and relaunch.”





Health
Flavanols are linked to better memory and heart health – here’s what foods you can eat to get these benefits – Yahoo Canada Sports
There are plenty of good reasons to make sure you’re eating enough fruit and vegetables each day. Not only do fruit and vegetables contain many of the important vitamins and minerals our body needs to function at its best, they also keep our gut healthy and may even help maintain a healthy weight.
But some plant foods may be more beneficial for health than others, thanks to a group of compounds called flavanols.
For instance, a recent study I helped conduct showed that people who eat a diet high in flavanol-rich foods may have better memory compared to those who have a low intake. A previous study also found that people with a low intake of flavanols were at higher risk of heart disease. Overall, there’s convincing evidence that consuming enough flavanols has health benefits.
But while research shows that flavanols have many health benefits, it’s important for consumers to know that not all flavanol-rich foods contain the same amount of flavanols – meaning some may be more beneficial to health than others.
Plant compounds
Flavanols are a group of compounds that are found in many plants – including apples, berries, plums and even beverages such as tea.
There are two main groups of flavanols, with many different subgroups. Each plant will contain different combinations of flavanols, as well. These compounds each have different structures and different effects on the body. That means that not all flavanols are created equal.
For example, a portion of blueberries and a cup of tea may contain the same amount of total flavanols – but they are made up of completely different types of flavanols, which may have completely different health effects.
So in order to investigate the health effects of flavanols, it’s therefore important to use a source which includes a wide range of different types. This is why flavanols extracted from cocoa are an ideal model, as they contain the two main types of flavanols. It also allows researchers to calculate which other foods are likely to have benefits based on how similar the compounds they contain are to cocoa flavanols.
Since foods such as cocoa, berries and tea contain a combination of many types of flavanols, it’s currently not clear which individual compounds generate health benefits. But some research has linked the specific flavanol epicatechin with better vascular function. Cocoa and tea both contain epicatechin.
Many different types
Another thing to know is that even if a food contains flavanols, it may contain lower amounts compared to others.
To better understand how flavanol intake affects health, a few years ago we developed a test that uses urine to measure flavanol intake. The test is based on the way the human body processes flavanols and tells us whether someone has eaten large amounts, small amounts or no flavanols at all.
Using this test, we were able to show that people with high flavanol intake had lower blood pressure and better memory than those with lower intake.
When we developed the urine test, we also investigated how it is affected by different types of flavanols and foods. This allowed us to estimate what amount of different flavanol-rich foods a person needs to consume to achieve approximately 500mg of flavanols per day – similar to the amount used in studies, which has been shown to have clinical benefit.
According to our research, only two-and-a-half cups of green tea are needed daily to get the recommended 500mg of flavanols. Just under a cup of millet (sorghum grain) can also provide you with the recommended daily amount.
But if you were to try and get your flavanols from one type of fruit and vegetable, our research shows you’d need to consume large amounts of each to achieve the recommended amount. For example, you’d need to consume nearly 15 cups of raspberries alone to get 500mg of flavanols.
As such, the best way to get enough flavanols daily is by consuming a combination of different fruits and vegetables. For example two apples, a portion of pecan nuts and a large portion of strawberries can achieve the 500mg target – or a salad made with millet and fava beans.
It’s also important to note that while the flavanols used in many studies were extracted from cocoa, unfortunately chocolate (even dark chocolate) is a very poor source of flavanols – despite what some headlines might claim. This is because these flavanols are lost during processing.
Although there’s still much we don’t know about flavanols – such as why they have the effect they do on so many aspects of our health – it’s clear from the research we do have that they are very likely beneficial to both memory and heart health.
This article is republished from The Conversation under a Creative Commons license. Read the original article.



Gunter Kuhnle has received research funding from Mars, Inc., a company engaged in flavanol research and flavanol-related commercial activities.
Health
'Social deprivation' speeds up aging, and death: McMaster study – Hamilton Spectator


We are dying every day, wrote Seneca, a stoic philosopher in ancient Rome.
And if you struggle living alone or have weak familial bonds, you risk speeding up death by as much as one year, according to findings published by McMaster University on Monday.
The new study shows that biological clocks tick faster for those dwelling in an environment of social deprivation (a dearth of family or community network resources) or material poverty, such as lacking access to quality housing, healthy food and recreation.
McMaster’s Divya Joshi, the study’s first author, said the findings indicate that living in a “deprived urban neighbourhood” marked by either form of deprivation is associated with “premature biological aging.”
Joshi is a research associate in the university’s Department of Health Research Methods, Evidence and Impact.
“If your (biological) systems are aging faster than your chronological age, then you will have more poor health outcomes, or quicker health outcomes, than someone who is aging slower biologically,” she told The Spectator.
The study analyzed DNA from the blood samples of 1,445 participants across Canada, who are part of the Canadian Longitudinal Study on Aging that is following 50,000 people between age 45 to 85.
“Epigenetic clocks” studied in the samples — also called “DNA methylation-based estimators” — indicated aging at the cellular level, she said.
“To be able to see that living in a socially or materially deprived neighbourhood impacts your healthy aging; that it increases your risk of epigenetic age acceleration by almost a year, beyond your individual health status — I think that is just remarkable,” she said.
When your biological age outpaces your calendar age, she said you have a greater risk of cardiovascular disease, respiratory conditions and neurological disorders that present a “greater risk of premature mortality.”
The findings fit their research hypothesis, she said, but what didn’t fit was the assumption that depression in the test subjects would further “amplify” the rapid aging effect.
In fact, while depression symptoms also contributed to epigenetic aging, environmental factors impacted aging acceleration regardless of depression symptoms.
The findings were published June 5 in “The Journals of Gerontology, Series A: Biological Sciences and Medical Sciences.”
McMaster professor Parminder Raina led the research team, which included investigators from the Netherlands, Norway and Switzerland, according to a news release.
While the presentation of the findings focused on the connection to disadvantaged neighbourhoods, Joshi agreed that an individual will age more rapidly when deprived of familial or social bonds, regardless of where they live.
“That is true, there is evidence that those people who have poor social networks or broken family units have a greater risk of higher epigenetic age acceleration … It is aging you, and that is so relevant coming out of the pandemic, and the isolation many people experienced, especially the toll it had on our older populations.”
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Health
Sudbury health unit offers advice about West Nile Virus – Sudbury.com

The Sudbury health unit is warning area residents to be wary of the possibility of being infected with West Nile Virus.
“Whether you are spending time in your backyard, exploring local trails, or vacationing in Ontario, getting bitten by mosquitos puts you at risk of being infected with West Nile virus,” said the release from Public Health Sudbury and Districts.
The release also said the risk is low, but it is still possible.
“Although the overall risk of becoming infected with West Nile virus is low, everyone is at risk and preventing bites is important to protect yourself and your family,” said Ashley DeRocchis, an environmental support officer with Public Health Sudbury & Districts.
Citizens are advised to use an insect repellent approved by Health Canada and follow the application recommendations on the package.
Also, during the times of day when mosquitoes are most active — during dusk and dawn — people might choose to stay indoors if possible.
The health unit also advised that people can wear light-coloured clothing, including long sleeves, long pants, socks, and a hat whenever they are outdoors. Consider the use of mesh “bug jackets” or “bug hats,” the news release said.
At home, people can check their window and door screens to ensure that there are no tears or holes for mosquitoes to get through. Also, don’t give the bugs a place to lay eggs.
Mosquitoes need only a small amount of calm, standing water to lay their eggs and for larvae to hatch, said PHSD.
Reduce mosquito breeding areas by changing or removing standing water at least once a week from areas such as bird baths. old tires, containers, barrels, flower pot saucers, swimming pool covers, wading pools, clogged gutters and eavestroughs, clogged drainage ditches, small containers like cans or bottle tops and unused children’s toys, said the release.
The health unit said symptoms of West Nile virus can range from mild to severe, from flu-like symptoms to severe nausea and even loss of consciousness.
Public Health Sudbury & Districts will be trapping and testing mosquitoes again this year starting in mid-June and continuing into the fall of 2023, said the release. For more information on West Nile virus, visit the website at phsd.ca or call Public Health Sudbury & Districts at 705-522-9200, ext. 464 (toll-free 1-866-522-9200).
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