Wegovy has been approved by the US Food and Drug Administration (FDA) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advance fibrosis but without cirrhosis.

What it means is that FDA has granted approval to Novo Nordisk's once-weekly 2.4 mg semaglutide subcutaneous injection for treating a liver cell damage, formerly known as NAFLD or nonalcoholic fatty liver disease. This is a condition where excess fat builds up in the liver, unrelated to heavy alcohol use. It is characterized by fat accumulation in the liver, inflammation, and liver cell damage that could potentially lead to fibrosis and cirrhosis. It is also closely linked to metabolic disorders like obesity and type 2 diabetes, which can be treated by Wegovy. Furthermore, the condition is also closely associated with high cholesterol.

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How Was The Approval Given?

The accelerated approval was given on the basis of part-one results from an ongoing two-part, phase 3 ESSENCE trial. This is where Wegovy demonstrated a significant improvement in liver fibrosis with no worsening of steatohepatitis. It also showed a resolution of steatohepatitis with no worsening of liber fibrosis as compared with placebo at week 72. The results were also published in April in The New England Journal of Medicine.

How Was The Trial Conducted?

The trial involved a total of 800 participants, who were assigned to either Wogovy (534 participants) or placebo (266 participants) in addition to lifestyle changes. The mean age was 56 years and the mean BMI was 54. Most patients were white, which comprised of the 67.5% of the participants, 57.1% of them were women and 55.9% of them were the patients with type 2 diabetes, while 31.3% of them (around 250 patients) had stage II fibrosis and 68.8% (550 patients) had stage II fibrosis.

It was noted that the patients were on stable doses of lipid-lowering , glucose-management, and weight loss medications.

At week 72, the trial’s first primary endpoint revealed that 63% of the 534 participants receiving Wegovy achieved resolution of steatohepatitis without worsening liver fibrosis, compared to 34% of the 266 participants on placebo, a statistically significant outcome.

For the second primary endpoint, 37% of those treated with Wegovy showed improvement in liver fibrosis without worsening steatohepatitis, versus 22% in the placebo group, again demonstrating a significant difference.

READ MORE: Weight Loss Drugs Like Ozempic, Mounjaro And Wegovy Under Scrutiny After Deaths And Pancreatitis Reports in UK

What Lies Ahead For Wegovy?

Novo Nordisk has moved forward with key regulatory submissions for its obesity treatments in 2025. The company filed for approval of its therapies in the European Union in February, followed by a regulatory submission in Japan in May. That same month, the U.S. Food and Drug Administration (FDA) accepted a filing for oral semaglutide 25 mg.

Looking ahead, part 2 of the ESSENCE trial is expected to report results in 2029. The study is designed to evaluate whether Wegovy can reduce the risk of liver-related clinical events in patients with metabolic dysfunction–associated steatohepatitis (MASH) and F2 or F3 fibrosis, compared with placebo, over 240 weeks.

While Novo Nordisk has the technology to manufacture semaglutide in pill form, the company emphasized that the U.S. launch of oral semaglutide for obesity will depend on portfolio priorities and manufacturing capacity. The higher-dose 50 mg oral version has not yet been submitted to regulators.

“The oral form requires more active pharmaceutical ingredient (API),” a spokesperson told Medscape Medical News. “With a fixed amount of API, the injectable form allows us to treat more patients. We are expanding oral and injectable production capacities worldwide, but it takes time to build, validate, and scale these processes.”

Valley Fever California: As cases of Valley fever increase in California, California Department of Public Health (CDPH) have put out a warning to ensure people stay safe. With more than 5,500 cases of valley fever in the first six months, the current number of cases being 6,761, health officials have detailed things California residents or visitors should know.

The highest rates of Valley fever are in the southern San Joaquin Valley, but cases are increasing in other parts of the Central Valley and the Central Coast. According to CDPH Director Dr. Erica Pan, it's crucial for residents, visitors, and healthcare providers to be aware of the signs and symptoms for early detection.

What is Valley Fever?

According to the Centre of Disease Control And Prevention, Valley fever (coccidioidomycosis) is a lung infection caused by the fungus Coccidioides, which lives in the soil. This fungus is found primarily in the Pacific Northwest and southwestern United States, as well as parts of Mexico, Central America, and South America. People become infected by breathing in the fungal spores.

It's important to note that Valley fever is not contagious; it cannot be spread from person to person or from animals to people. While some people who are exposed to the spores never get sick, others develop symptoms of a typical lung infection, such as a cough and fever.

The disease can be challenging to diagnose because its symptoms are similar to those of other viral or bacterial pneumonias, leading to potential misdiagnosis, ineffective treatments, or delays in getting the proper care. Early treatment with antifungal medication can be lifesaving for those who need it.

What Are The Symptoms of Valley Fever?

The illness can cause symptoms that resemble the flu or COVID-19, and it can also lead to serious lung infections like pneumonia. The fungus is often stirred up in late summer and fall, and people typically get sick one to three weeks after breathing it in. The symptoms of Valley fever can vary greatly from person to person. While some individuals have no symptoms at all, others may experience:

• Fatigue (tiredness)
• Cough
• Fever and headache
• Shortness of breath
• Night sweats
• Muscle aches or joint pain
• Rash on the upper body or legs

Is Valley Fever A Serious Health Concern?

In some cases, Valley fever can lead to more serious health issues. About 5 to 10% of people who contract the infection will develop long-term problems in their lungs.

In a very small percentage of cases (about 1%), the infection can spread from the lungs to other parts of the body. This is known as a disseminated infection and can affect the skin, bones, joints, or even the brain, leading to a condition called meningitis. Certain groups of people are at a higher risk for developing these more severe forms of the illness.

How Is Valley Fever Treated?

Many people who get Valley fever get better on their own without needing any special medicine. Their symptoms usually go away in a few weeks or months. However, some people need medical care to feel better or to keep the infection from getting worse.

For very bad infections or cases where the fungus has spread to other parts of the body, doctors must use antifungal medication. These people may also need to stay in the hospital.

How To Prevent Valley Fever?

Valley fever is not contagious, so you can't catch it from another person or pet. You and your pets can only get it by breathing in dust that contains the fungus. It can be hard to completely prevent Valley fever, but you can take steps to lower your risk:

• Stay inside on days when it's windy and dusty. Keep your windows and doors shut.
• Keep your car windows closed when driving through dusty spots and use the air conditioning on the recirculated air setting if you can.
• Spray water on soil or dirt before you dig to keep dust from flying into the air.
• If you have to be outside in a dusty area, wear a properly fitted N95 mask.

First case of Rocky Mountain spotted fever or RMSF, which is a tick-borne disease has been confirmed in Quebec. The case has been confirmed by the doctor on Monday and the patient, infected in the Eastern Townships is said to have responded well with the treatment.

As per Dr Alex Carignan, an infectious disease microbiology and professor at the Faculty of Medicine and Health Sciences at the University of Sherbrooke, since the temperatures are rising and warming up, more of such cases could be infected. He told Le Devoir, "It is worrying because it is an infection with significant severity."

What Is Rocky Mountain Spotted Fever?

As per the Centers for Disease Control and Prevention (CDC), RMSF is a bacterial disease spread through the bite of infected tick. As per the National Institute of Health (NIH), US, it is an acute febrile tick-borne illness caused by Rickettsia rickettsii, and is most severe and most common form of the rickettsial infections in North America.

The disease can be treated with antibiotics, however if not treated in time, it could be fatal too. The NIH notes that the R. rickettsia transmits into human hosts by the bite of an infected tick. Humans are not a natural reservoir of disease. The Rickettsia does not harm the tick.

The Common Symptoms Are:

• High fever
• Headache
• Muscle Pain
• Stomach Pain
• Lack of appetite
• Skin lesion in forms of red spots

The symptoms appear within few hours of being bitten.

How Does It Spread?

CDC notes that in the US, the most common source is the American dog tick or the Dermacentor variabilis. In parts of southwestern United States and Mexico, it is also spread by the Brown dog tick or the Rhipicephalus sanguineus. There is another source the Rocky Mountain wood tick or the Dermacentor andersoni, which is also a significant source of RMSF.

In terms of Canada, Dr Carignan notes that the tick species has been present in Quebec for several years now. "We expected to see the first cases appear within five to ten years. But it's finally now. So, we have to adapt accordingly," he told Le Devoir.

Is This Same As The Lyme Disease?

No, it is not. Unlike the black-legged tick, the American dog tick does not transmit Lyme disease. In addition to affecting humans, the Rocky Mountain spotted fever can also affect animals.

Prevention

Dr Carignan notes: "Taking a shower fairly quickly can also help dislodge any ticks that my be settling in."

The doctor advises that people must wear long clothing, use insect repellent, and check for ticks after they have been outdoors.

However, there is no vaccine to prevent RMSF, notes the CDC. The most common time for such cases, notes the CDC is between April to September.

The diagnosis is not too complicated. Your healthcare provider may order blood tests to look for evidence of RMSF, the results, however, can take a few weeks.

It is treated with antibiotic doxycycline, which, notes the CDC, has been approved for all ages. The NIH, US, notes that without prompt antibiotic treatments, the mortality rates could go as high as 20 to 30% in the case of RMSF.

Ozempic Lawsuit: "This week's study doesn't suggest that GLP-1 cause your eyes to fall out exactly, but, as you will see in a second, it is not that far off," says Dr F Perry Wilson, MD, MSCE, physician, researcher, educator, and writer, at Yale School of Medicine, before he begins to explain what the new study suggests of the side effects.

Weight loss drugs have gained popularity up recently. The popularity is for all the right, and the wrong reasons too. While up recently, we have Wegovy being approved for treating MASH, we also have unheard side effects of the popular drug Ozempic, and not to mention, the cases of pancreatitis reported in the UK, and the ongoing lawsuit on Ozempic.

So, what does this new study add to all this?

Weight Loss Medication And Vision Loss

Two studies, published in JAMA, analyzed how semaglutide, an injection used to treat type 2 diabetes that helps control your blood sugar, and tirzepatide, an antidiabeteic medication, also used to treat type 2 diabetes and for weight loss, administering via injections, which include popular drugs like Ozempic, Wegovy, Mounjaro and Zepbound, impacted eye health in Americans with type 2 diabetes over a 2-year period.

What Did The Study Find?

One of the studies found a modest risk of developing a non-arteritis anterior ischaemic optic neuropathy (NAOIN), which is a rare eye condition that can lead to sudden vision loss due to lack of blood flow. This condition has close links with the consumption of semaglutide and tirzepatide.

Out of more than 159,000 participants with type 2 diabetes, 35 developed NAION, compared to 19 people in the comparison group. The Ohio-based researchers also noted an increased risk of developing "other optic nerve disorders" identified in 93 patients.

The second study found no statistically significant link between GLP-1 drug use and NAION, a rare eye condition, but reported a slight uptick in cases of diabetic retinopathy, a retinal disease that can cause vision loss.

The study observed that individuals with type 2 diabetes who were treated with GLP-1 drugs faced a modestly higher risk of developing diabetic retinopathy. However, researchers emphasized that fewer patients progressed to sight-threatening stages of the disease. They concluded that all patients with type 2 diabetes receiving GLP-1 therapies should undergo regular screening and monitoring for potential eye complications, regardless of whether they already have diabetic retinopathy.

"These findings suggest that all patients with type 2 diabetes treated with GLP-1 RAs, regardless of preexisting diabetic retinopathy, should be regularly screened and monitored for potential complications," the study authors concluded.

What Are The Experts Saying?

As questions continue to mount about the potential connection between GLP-1 weight-loss drugs and vision problems, experts stress that more research is needed before drawing firm conclusions.

Sue Decotiis, M.D., a medical weight-loss doctor in New York City, said she believes additional studies are required to confirm whether the drugs increase the risk of vision loss, pointing to conflicting findings so far.

"NAION is a rare condition of the optic nerve that, although serious, has not really been shown to be increased by these studies," Decotiis, who was not involved in the research, told Fox News Digital. "We need more studies for certain."

She noted that diabetic patients already face a heightened risk of eye disease due to blood flow and nerve damage. "Eye complications are often directly related to the degree or lack thereof of diabetes control," she explained.

According to Decotiis, GLP-1 drugs often help reduce the severity of type 2 diabetes, which can in turn lower the risk of eye disease. These medications have also been shown to reduce cardiovascular risks, such as hypertension, and improve circulation, both of which may benefit eye health.

For patients beginning GLP-1 treatment, she advised proactive monitoring. "We should take precaution with methodical ophthalmic care for diabetics on these drugs," she said. "However, let’s not throw the baby out with the bath water."

Ashley Brissette, M.D., an ophthalmologist in New York City, echoed that perspective, calling NAION an "extremely rare" but serious medical condition. She emphasized that the risk associated with GLP-1 drugs is also “extremely rare, at a risk of about one in 10,000, according to other studies.”

"I think caution with anything is warranted," Brissette told Fox News Digital. "And remember these are associations, not causations, so it's not to say that GLP-1 use causes NAION or worsening retinopathy, but their use is associated with these conditions."

She underscored the importance of thorough eye care: "From an ophthalmologic standpoint, these findings underscore the importance of baseline and follow-up eye examinations for patients starting GLP-1 therapy, especially those with pre-existing retinal or optic nerve risk factors."

Brissette added that while the benefits of GLP-1 drugs in reducing cardiovascular and metabolic risks are “substantial,” patients should be counseled on potential vision-related side effects, and “any sudden visual symptoms should prompt immediate ophthalmic referral.”

When contacted by Fox News Digital, Novo Nordisk, the maker of Ozempic and Wegovy, said it stands by the safety of its medications.

"Patient safety is a top priority for Novo Nordisk, and we take all reports about adverse events from the use of our medicines very seriously. NAION is a very rare eye disease, and it is not an adverse drug reaction for the marketed formulations of semaglutide (Ozempic, Rybelsus and Wegovy) as per the approved labels in the U.S."

The company added: "Novo Nordisk, on its part, has conducted an analysis across randomized controlled clinical trials with GLP-1 receptor agonists, including a blinded ophthalmologist evaluation to confirm NAION diagnoses. Our current assessment is that these data do not suggest a causal relationship between GLP-1 RA use and NAION events."