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FDA issues draft guidance for developing drugs for NASH with cirrhosis

Although there is not yet any Food and Drug Administration-approved drug for treating nonalcoholic steatohepatitis, the agency on Thursday issued a draft guidance for companies developing drugs among NASH patients with cirrhosis who do not yet display symptoms.

The draft guidance, “Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment,” was announced in the Federal Register on Friday. Public comment is being accepted through Aug. 6. It accompanies a draft guidance issued last year for NASH with liver fibrosis, but without cirrhosis.

The guidance lays out considerations for companies developing clinical trials for NASH with compensated cirrhosis, which occurs when there is scarring of the liver, but patients still appear healthy.

In particular, the agency said it will likely only evaluate drugs for compensated NASH under the traditional approval pathway, not accelerated approval. This is because it said “currently there is insufficient evidence to support the use of histological improvements as a surrogate endpoint that is reasonably likely to predict clinical benefit to support accelerated approval.”

NASH is a growing global health concern, rising in tandem with the rise in Type 2 diabetes and obesity. According to some reports, the NASH market’s value is expected to jump from $1.17 billion in 2017 to more than $21 billion by 2025.

Although there are not yet any approved drugs for the disease, New York-based Intercept Pharmaceuticals could become the first to win such an approval after the announcement in February of positive Phase III data from its REGENERATE study of Ocaliva (obeticholic acid) in NASH with liver fibrosis, meaning Stage 2 or Stage 3. Intercept is running another Phase III study, REVERSE, in patients with compensated cirrhosis, also known as Stage 4.

Meanwhile, also in February, Gilead Sciences’ Phase III study of the drug selonsertib in NASH with compensated cirrhosis, STELLAR-4, failed. Two months later, the STELLAR-3 trial, testing the drug among patients with Stage 3 liver fibrosis, also failed. STELLAR-3’s failure was in line with investment analysts’ expectations and effectively leaves selonsertib dead in the water.

Photo: Sakramir, Getty Images

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New blood test on horizon for the 1 in 10 children who suffer common liver disease

A new blood test could become clinical practice within five years, reducing the need for a liver biopsy in the management of paediatric Non-Alcoholic Fatty Liver Disease (NAFLD), as a major new international paediatric liver registry collaboration yields early results.

Researchers are today presenting findings, at the 52nd Annual Meeting of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition, which indicate that blood tests could replace the need for a liver biopsy in children suffering with NAFLD. Currently, if a doctor is concerned a child has scarring or inflammation of the liver they may recommend a liver biopsy. The study looked at 67 children with NAFLD and found that different types of fats in the blood were associated with features of fatty liver on liver biopsy, allowing researchers to determine the presence of inflammation and scarring—also known as non-alcoholic steatohepatitis and fibrosis.

Non-Alcoholic Fatty Liver Disease affects around one in 10 children and is the most common paediatric liver disorder. It can progress to advanced scarring (cirrhosis), liver failure, and liver cancer. Despite this, the natural history of the condition is poorly understood and there are currently no approved treatments or drugs in clinical trials for children. In response to this, researchers from across Europe have come together to pool resources in order to better understand the condition and how to treat it.

Liver biopsy is currently the most accurate test for NAFLD and the only method routinely used in practice for assessing the presence of scarring or inflammation. However, biopsy is invasive, resource intensive, costly, prone to sampling error and carries a small risk of significant complications. Therefore, the availability of an accurate and non-invasive marker to replace the need for liver biopsy, both in routine practice and in a clinical trial setting, is a major breakthrough for children, parents and healthcare professionals.

To date, all European drug trials and assessments of non-invasive markers in paediatric NAFLD have been single-centre studies, which limits the generalisability of findings. This is particularly pertinent given the variation in clinical practice at different centres.

This research is the first major finding to be reported from the European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNALFD registry), an international collaboration of 11 specialist and non-specialist centres in six European countries, led by Dr. Jake Mann. When fully operational, the registry will have enrolled up to 2,000 children, including 500 with biopsy-proven paediatric NAFLD, and follow-up will continue for up to 30 years.

Commenting on the findings, registry co-ordinator Dr. Jake Mann said:

"It is early days but the results of the research are promising and could help shift the way we understand and manage paediatric NAFLD: saving resources, time, and stress for children and their parents. The new multi-centre registry provides us with an opportunity to tackle these challenges. The EU-PNAFLD registry will facilitate recruitment into interventional clinical trials as well as imaging, biomarker, and translational studies, plus allow greater understanding of the long-term natural history of NAFLD. The ultimate aim is to understand the condition sufficiently to intervene and slow disease progression so we can reduce the number of patients requiring liver transplantation later in life."

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The 7 Best Foods for Your Liver

There are some things that can be bad for your liver, like heavy drinking or taking high doses of medications. However, certain foods can be good for your liver health, too. And it’s super important to keep your liver healthy, as it’s a powerful organ that handles a ton of functions that our bodies need to run smoothly.

“The liver completes very important functions no other organ can perform. And once the liver is severely damaged, there's no way to treat it medically, other than a liver transplant, which is a very serious proposition with a lot of downsides,” says Suzanne Dixon, registered dietitian with The Mesothelioma Center.

What does the liver do, exactly? The liver's main job is to filter the blood coming from the digestive tract, before sending it out to the rest of the body, and it detoxifies chemicals and metabolizes drugs to keep the body safe. “In summary, we simply cannot live without our livers,” she says, so it’s pretty important to fuel it with the right foods and to live a healthy lifestyle to protect it from harm.

What role does food play in liver health?

Food can play a critical role in liver health. “In fact, health experts have noted there has been a big increase in NAFLD or non-alcoholic fatty liver disease. This is a sign of damage to the liver that isn't due to overindulging in alcohol,” says Dixon. Alcohol abuse is a major cause of liver problems in the U.S., but now doctors are seeing more cases of liver damage, manifesting as fatty liver, in young people with no history of heavy drinking, where food is often to blame.

That being said, the best thing you can do is maintain a healthy body weight and avoid simple carbohydrates and sugars, like high fructose corn syrup, as well as to drink alcohol and take medication in moderation, says Dixon. (Unless you’re prescribed high doses from a doctor.)

You should also load up on healthy foods that nourish your liver and help it function. These are the best foods to eat for optimal liver health—and good news, they’re pretty tasty, too!


Artichokes can help protect your liver from damage. “Compounds found in this food are studied for their ability to prevent liver-damaging toxins from entering liver cells. In fact, artichokes are in the same plant family as milk thistle, an herbal product used to promote liver health,” says Dixon. Enjoy roasted with some olive oil or add to a salad for extra fiber and nutrition.


Beans are loaded with healthy fiber, which is known to support a healthy microbiome (your gut health). A healthy microbiome, in turn, is linked to improved liver health, says Dixon. Use beans as a plant-based source of protein and fiber to stay full longer and to help purify your liver.


“As with beans, it's all about the microbiome. Only in this case, instead of supplying the ‘food’ (fiber) your microbiome bugs like to eat, the yogurt actually replenishes the microbes themselves,” says Dixon, as yogurt contains probiotics, which are those beneficial gut-friendly bacteria. Get unsweetened, plain Greek yogurt to keep added sugar low and to reap those probiotic benefits.


Believe it or not, your morning cup of joe has some liver protective effects, and while it’s not a food, it’s definitely something people love to drink for energy and flavor. “Coffee is noted for its ability to prevent the build up of fat and connective tissue (both are present in liver disease) in the liver,” says Dixon. “Coffee also appears to reduce inflammation in the liver and increase levels of antioxidants the body naturally produces (called glutathione),” she says.

Coffee beans are rich in antioxidants, so try to enjoy it in its pure state if possible. “Just make sure you stick to coffee black or with just a splash of cream or a small spoonful of sugar. Skip the fluffy, fancy coffee drinks that are loaded with sugar and calories,” she says.

Bright Purple and Red Berries

“Blueberries, blackberries, cranberries and similar foods are loaded with a group of compounds called polyphenols. These substances appear to protect liver cells from damage and supply antioxidants to reduce free-radical damage in liver tissue,” says Dixon. Add some to yogurt for double the benefits, or enjoy a handful when you’re craving something sweet and satisfying.

Cruciferous Vegetables

Here’s another reason green vegetables are so good for you. Cruciferous vegetables (think: broccoli, cauliflower, kale, chard, mustard and collard greens, bok choy, watercress, horseradish, cabbage, and Brussels sprouts) support the liver's ability to detoxify the many less-than-healthy things we come into contact with (hello breathing, eating, and drinking) every day.

These veggies have quercetin, which has been shown to have positive effects on the liver. Filling up on these greens may also reduce risk for liver cancer, says Dixon.

Fatty Fish and Nuts

Healthy sources of fat reduce inflammation, which keeps your liver healthy. “This, in turn, appears to protect the liver from damage and day-to-day wear and tear,” says Dixon. Enjoy at least 2-3 servings of fish a week, and munch on nuts when you need a snack. Yet, limit to a handful or so to keep calories and fat in check—there’s quite a bit of both per serving.

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