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By Nancy Lapid, Health Science Editor

Hello Health Rounds readers! Today we highlight presentations over the weekend at two major medical meetings that suggested that a couple of potentially practice-changing pharmaceuticals – one for fatty liver disease and one for type 2 diabetes – are coming closer to regulatory approval. We also share data showing that a cancer diagnosis in childhood or young adulthood carries a long-term risk of mental health problems.

In breaking news, see these stories from our Reuters journalists: Merck accused of downplaying asthma drug’s brain impact; weight loss drug candidates multiply; Wegovy’s popularity has employers rethinking insurance coverage; malaria cases diagnosed in Florida and Texas; and new Lysol spray destroys airborne coronavirus.

Among our industry news stories: J&J’s talc settlement tested in bankruptcy court; Merck, Ridgeback withdraw COVID drug application in EU; Walgreens cuts profit forecast; Fresenius Medical Care shares drop; GSK’s gonorrhoea vaccine gets FDA ‘fast-track’ designation; Illumina starts job cuts; Lilly next-gen obesity drug leads to 24.2% weight loss in trial; and UK watchdog wants more info on Lilly’s Mounjaro.

Drug development efforts are yielding exciting new first-of-a-kind treatments: a pill that reduces or reverses fatty liver disease, and a form of insulin that only needs to be injected once a week. REUTERS/Adam Jourdan.

An experimental drug for fatty liver disease met all of its goals in a late-stage study, researchers reported on Friday at the annual meeting of the European Association for the Study of the Liver in Vienna.

In a randomized trial, resmetirom from Madrigal Pharmaceuticals reduced the amount and severity of liver damage compared to a placebo in 966 patients with NASH, or non-alcoholic steatohepatitis. Most patients also had diabetes.

Roughly 25% to 30% of people worldwide have fatty liver disease, and about 25% of those have NASH, study leader Dr. Stephen Harrison of Pinnacle Clinical Research and Summit Clinical Research in San Antonio, Texas, said at a press conference.

In NASH, liver inflammation from fat leads to scarring, or fibrosis, and eventually to cirrhosis, liver failure, liver transplantation or death. Risk factors include obesity, gastric bypass surgery, high cholesterol and type 2 diabetes.

Resmetirom would be the first approved treatment and its impact on clinical practice would be huge, Harrison said.

NASH is likely under-diagnosed because without a way to treat it, doctors are reluctant to test for it in patients without symptoms, he said.

“Now … we are at the forefront of treatment,” and NASH is more likely to be diagnosed and treated before liver failure develops, Harrison said.

After one year of treatment, NASH had been resolved in 27% of those receiving resmetirom and in 10% of those taking placebo, liver biopsies showed.

Scarring severity decreased in roughly 25% of resmetirom-treated patients versus 14% of the placebo group.

The U.S. Food and Drug Administration has designated resmetirom a “breakthrough therapy” and granted it fast-track status in the approval process.

Read about other experimental drugs for fatty liver disease on Reuters.com

• Akero says NASH drug shown to reduce liver fat by 65% in some patients
• Hepion’s NASH drug meets main goal in mid-stage trial
• FDA declines to approve Intercept’s fatty liver disease drug

In people with type 2 diabetes transitioning from oral medications to insulin, an experimental once-a-week insulin injection controlled blood sugar more effectively than a daily injection, according to two separate trials presented on Saturday at the annual meeting of the American Diabetes Association.

In a 78-week trial, researchers randomly assigned nearly 1,000 patients whose diabetes was not well-controlled with pills to start treatment with once-weekly injections of insulin icodec from Novo Nordisk or once-daily shots of insulin glargine U100 (Lantus, from Sanofi-Aventis).

A year later, the average reduction in HbA1c – a marker of blood glucose levels over the past three months – was 1.55 percentage points with icodec versus 1.35 points with glargine, according to a report in The New England Journal of Medicine.

The percentage of time spent with blood sugar in the normal range was 71.9% with icodec and 66.9% with glargine, and there was no significant difference between groups in rates of low-blood-sugar episodes or adverse side effects at one year, the researchers reported.

In a separate trial, nearly 600 patients about to initiate insulin treatment for poorly controlled type 2 diabetes were randomly assigned to receive icodec or daily shots of Novo-Nordisk’s insulin degludec. After six months, HbA1c reductions were greater with icodec, according to a report in JAMA.

If approved, icodec would be the world’s first once-weekly basal, or long-acting, insulin.

The authors of both reports say the once-weekly insulin regimen might improve treatment adherence by reducing patients’ injection burden.

Childhood cancer survivors are at high risk for poor mental health, researchers warned on Friday at a meeting of cancer experts.

The researchers pooled data from 52 earlier studies comparing mental-health outcomes of children, adolescents and young adults with cancer to outcomes in their healthy siblings and in similar unrelated individuals.

Altogether, the studies included 27,613 cancer survivors and 274,539 controls without cancer.

The cancer survivors had a 57% higher lifetime risk of depression and a 56% higher risk of psychotic disorders compared to both their siblings and the unrelated study subjects, according to a report in JAMA Pediatrics.

The cancer survivors also had a 29% higher risk of anxiety.

Suicide mortality was not significantly higher among the survivors overall, although patients diagnosed in adolescence did have an increased risk of death from suicide.

Depression and anxiety disorders were most common in survivors older than 30 and 25 years, respectively.

An editorial published with the study notes that people who survive having cancer at a young age “may not fully appreciate the cumulative burdens of their experience until later in life,” when they are looking for jobs, trying to start families and more likely to have complicated and ongoing health problems.

With the results of this study, the editorial continues, “We can put the debate about survivors’ mental health risks to rest … And devote our energies to determining how to meet the needs of each patient.”

Read more about cancer survivorship on Reuters.com

• Italy to pass ‘right to be forgotten‘ law for cancer survivors

This newsletter was edited by Mark Porter. Additional reporting by Shawana Alleyne-Morris.

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