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New Insulin Treatment Sparks Safety Concerns at FDA 

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United States: Among the most common diabetes treatments that most diabetes patients need are insulin therapies that involve injections done daily to maintain IAVL glucose levels. 

Nonetheless, a project that involves a weekly insulin injection is likely to attract the approval of the FDA, although a team made of staff advisors of the agency is still in doubt in terms of the efficiency of the new product in addressing some of the risks. 

FDA deliberation on Novo Nordisk  

In another development, during a Friday meeting, the Endocrinologic and Metabolic Drugs Advisory Committee, jointly with the FDA, discussed the risks and advantages of the weekly insulin icodec developed by Novo Nordisk. It will be an important addition to the existing diabetes medications because if approved by the agency, CNN Health noted that this will be one of the first weekly insulin products in the United States. 

The committee debate was based on two aspects: the safety and efficacy of insulin icodec in patients with type 1 diabetes. 

With regards to the question of whether Novo Nordisk has provided evidence that expanding the scope of representation of insulin icodec provides utility in improving glycemic control for adults with type 1 diabetes. 

New Insulin Treatment Sparks Safety Concerns at FDA. Credit | Getty Images
New Insulin Treatment Sparks Safety Concerns at FDA. Credit | Getty Images

Details of the advisory committee’s deliberations and votes will be disclosed and conveyed to the FDA for evaluation; while it is not obligatory to heed the advisory committee, the FDA considers the matter before deciding whether to approve the treatment. 

Clinical trials analysis 

In a comparative study of Phase 3 clinical trials, researchers reported that once weekly insulin codec was more effective in controlling high blood sugar than insulin degludec daily therapy but was accompanied by more cases of low blood sugar, hypoglycemia evidenced by loss of consciousness, and seizures. 

According to the committee’s meeting materials, “Insulin icodec was associated with 50 to 80 percent more clinically significant or severe hypoglycemia compared to insulin degludec at Week 52, depending on the method of analysis,” as CNN Health reported. 

Dr. Barbara Onumah, a committee member and an endocrinologist in Largo, Maryland, who voted yes on the benefits of insulin icodec outweighing its risks, said, “This would add a tool to the toolbox for clinicians.” 

She added, “It will not be beneficial for every person, but it might be useful for some persons,” and, “There’s still a few risk mitigation things that need to be ironed out clearly so that for the general provider or practitioner who would be writing this prescription, should it be approved, will be doing it correctly and safely – because safety would be very important.” 

Moreover, Dr. Matthew Drake, a committee member and an endocrinologist at Mayo Clinic in Rochester, Minnesota, who voted no, stated that his rationale behind his action was on the basis of comparing insulin icodec with the current gold standard of insulin degludec, “which has a good safety profile in my experience.” 

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Mpox Vaccine Breakthrough: Hope for Global Eradication

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Mpox Vaccine Breakthrough: Hope for Global Eradication. Credit | AP

United States: The World Health Organization said on Friday that it had approved its first shot of vaccines against the mpox for use in adults, saying that it is a progression toward eradicating the disease in Africa.  

More about the news

This approval is significant for organizations like Vaccines Alliance Gavi and UNICEF as they can now purchase it from Bavarian Nordic A/S. 

Buying supplies is, however, a challenge since the product is manufactured by only one company. 

According to WHO Director-General Tedros Adhanom Ghebreyesus, “This first (authorization) of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa and in future,” ABC News reported. 

Previously, the UN health agency endorsed the two-dose mpox vaccine targeting the adult population who are 18 years and above. As for WHO, even though they did not advise the use of the vaccine for people below the age of 18, in particular cases, vaccines can be given to infants, children, and adolescents “in outbreak settings where the benefits of vaccination outweigh the potential risks.” 

What more has the WHO recommended?

The WHO has also pointed out that it has been making an “access and allocation mechanism” to execute an even and fair distribution of mpox tests, treatments, and vaccines to the countries that need them most. 

Mpox Vaccine Breakthrough: Hope for Global Eradication. Credit | Reuters

Mpox Vaccine Breakthrough: Hope for Global Eradication. Credit | Reuters

WHO has suggested that a dose could be split in the event that there is a shortage of the vaccine since one dose was proven to be 50 percent effective, and it is important to gather more information on the efficacy of the vaccine when used as a single shot. 

About the vaccine

The Bavarian Nordic mpox vaccine was earlier named and approved by several developed countries in Europe and North America during the mpox outbreak in the year 2022. 

In millions of adults, doses have proven that the vaccine assists in decelerating the virus distribution, but little is known about children. 

Director-general of the Africa Center for Disease Control and Prevention said last month that seventy percent of the patients are below the age of 15 in Congo, where the outbreak is most severe, and children under the age of 15 are the majority of fatalities at 85 percent. 

However, the WHO noted that more than 120 countries had confirmed more than 103 thousand legion cases of mpox since the start of the outbreak two years ago, ABC News reported. 

As of Sunday, it recorded 723 people in well over a dozen countries in Africa have perished from the disease. 

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9/11 Dust Exposure Linked to 14x Higher Dementia Risk

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9/11 Dust Exposure Linked to 14x Higher Dementia Risk. Credit | AP

United States: The World Trade Center Health Program has been covering the medical expenses for cancer, respiratory ailments, mental health conditions, and musculoskeletal disorders linked to work at the site ever since it was established by an act of Congress and signed into law by President Barack Obama in 2011. 

More around the news

Recently, researchers have started to look into cognitive impairment and dementia afflicting first responders at rates far higher than in the general population. 

The study findings are urging healthcare providers to be more expressive regarding lobbying the World Trade Center Health Program, which is overseen by the CDC, to include dementia among the illnesses covered. 

What more are the experts stating?

According to Benjamin Luft, the director of a program at Stony Brook University that cares for and monitors the health of first responders, “I’m hoping they will,” and “They have a systematic process in which they evaluate the scientific data. We’ve spent a huge amount of time and effort to establish that exposure to the neurotoxins and dust could cause these problems, and so should be eligible for coverage,” the Washington Post reported. 

9/11 Dust Exposure Linked to 14x Higher Dementia Risk. Credit | AP

9/11 Dust Exposure Linked to 14x Higher Dementia Risk. Credit | AP

Lust has been working as a senior author of a study whose findings were published this summer and involved more than five thousand respondents who regularly undergone tests for over a decade. 

They found that the ones with maximum exposure to the dust, as well as neurotoxic debris at the WTC, would have fourteen times more chances of becoming infected with dementia before the age of 65.

As per Ray Dorsey, a professor of neurology at the University of Rochester, the small-sized ordinary dust particles, which are termed fine particulate matter, could enter the nose and reach the brain to cause damage, the Washington Post reported. 

However, as Dorsey said, “The nose is the front door to our brain,” and “Dust and chemicals set up shop in the small area of our brain, then spread to the parts of the brain important for memory.” 

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FDA Approves Controversial Childhood Obesity Drug

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FDA Approves Controversial Childhood Obesity Drug. Credit | Shutterstock

United States: A drug has recently received approval for the treatment of obesity in adults and teenagers. It has been proven to be efficient for kids starting from the age of six when taken together with the necessary lifestyle changes – a new study found.  

More about the news

A medication called liraglutide, used in adults with obesity, reduced body mass, attenuated weight gain, and enhanced favorable biomarkers in children aged between six and eleven years, research reported in a medical conference on Tuesday, and to the New England Journal of Medicine, ABC News reported. 

Following the trial, the company that manufactures the drug, Novo Nordisk, has sought permission from the US authorities to apply the medication in children in that age bracket, the spokesperson said on Tuesday. 

Should the medication be approved, it would be the first treatment for the kind of obesity experienced by over 20 percent of kids in the age group of 6 through 11 in the United States, according to the US CDC. 

FDA Approves Controversial Childhood Obesity Drug. Credit | Shutterstock

FDA Approves Controversial Childhood Obesity Drug. Credit | Shutterstock

What do the study results show?

 According to Dr. Claudia Fox, a pediatric obesity expert at the University of Minnesota, who led the study, “To date, children have had virtually no options for treating obesity,” and “They have been told to ‘try harder’ with diet and exercise,” ABC News reported. 

Like most drugs with antiemetic properties, side effects include gastrointestinal effects in those administered the drug, including nausea, vomiting, and diarrhea, among others. 

However, physicians and parents would have to research those risks and the absence of knowledge about the safety of employing such drugs in young children. 

According to Dr. Melissa Crocker, a pediatric obesity specialist at Boston Children’s Hospital, “Having a medication for that age group, if approved, would be a really nice tool to have, but we’re also going to have to be careful about how widely we start using it,” ABC News reported. 

FDA Approves Controversial Childhood Obesity Drug. Credit | Adobe Stock

FDA Approves Controversial Childhood Obesity Drug. Credit | Adobe Stock

“And I would answer that differently at six than I would at 11,” she added. 

About Liraglutide

Liraglutide belongs to a class of drugs known as GLP-1s, which currently boast some of the biggest-selling drugs in the world, such as Wegovy and Mounjaro. 

The medications make them resemble hormones that control hunger, feelings of being full or satiated, and digestion. Although this drug is given as a daily injection, it has been approved under the name of Victoza as a treatment for diabetes in adults and in children that are at least ten years of age and for Saxenda under the treatment of obesity affecting adults and children aged between 12 to 17 years. 

The new study, also funded by Novo Nordisk, enrolled 82 children with a mean age of 10 and a baseline weight of 70kgs or 154. 2 pounds. In this sample, the average starting BMI was 31, categorizing the childhood population as obese or overweight. 

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