First NASH liver disease drug is here, more coming

[Pelican Press 0]

First NASH liver ******** ***** is here, more coming

3D Illustration of a human liver organ.

magicmine | iStock | Getty Images

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Good morning! Millions of Americans with a common and potentially life-threatening form of liver ******** will soon have access to the first-ever treatment for the condition. 

In a landmark decision on Thursday, the Food and ***** Administration approved Madrigal Pharmaceuticals‘ ***** “

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,” to be used along with diet and exercise. The company expects the medicine to be available

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with a hefty price tag of

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per year before insurance and other rebates. 

So, why is this approval so important? 

First of all, people suffering from the ******** badly need a treatment. Rezdiffra is

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to treat patients with nonalcoholic steatohepatitis, or NASH, who also have moderate-to-advanced liver scarring.

Some specialists have started calling the condition metabolic dysfunction-associated steatohepatitis, or

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, to avoid potentially stigmatizing language.

MASH is a serious form of liver ******** characterized by excess **** buildup and inflammation. It can lead to liver scarring and in more severe cases, liver ******** or *******. The condition is often associated with other health problems, such as high blood pressure, Type 2 diabetes and obesity.

Roughly 6 million to 8 million people in the U.S. have MASH with moderate-to-advanced liver scarring, according to an

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cited by the FDA. 

The agency’s approval is also a big deal because it means Madrigal has succeeded in an area where several other drugmakers have

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– or are still trying to ******. 

That gives Madrigal an edge in a market that could be huge: The MASH industry could be worth nearly

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across the U.S., France, Germany, Italy, Spain, the U.K. and Japan, according to an estimate from data analytics firm GlobalData. 

Madrigal’s ***** is setting the bar for efficacy and safety for MASH treatment, while also opening the door for medicines still in development. 

There’s one important detail in the approval that could bode well for the entire MASH space: The FDA isn’t requiring patients to get a liver biopsy to determine their eligibility for Madrigal’s *****. 

That refers to a

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in which a doctor removes a small piece of liver tissue from a patient so they can examine it under a microscope for signs of damage or ********. 

“The absence of liver biopsy requirement in Rezdiffra’s label should buoy biotech stocks” of companies developing MASH treatments and “potentially accelerate and broaden patient access,” William Blair analyst Andy Hsieh wrote in a note Friday.

In this photo illustration, the Madrigal Pharmaceuticals logo is displayed on a smartphone screen. 

Rafael Henrique | SOPA Images | Lightrocket | Getty Images

There are a handful of biotech companies with promising experimental MASH treatments: 

But the question for all of those companies is how much a blockbuster class of drugs called GLP-1s will dominate the MASH market. 

GLP-1s work by mimicking a hormone produced in the gut to suppress a person’s appetite and regulate blood sugar. 

They include Novo Nordisk‘s weight loss ***** Wegovy and diabetes treatment Ozempic. Eli Lilly‘s respective weight loss and diabetes injections Zepbound and Mounjaro are also part of the class, but target an additional hormone called GIP. 

• Novo Nordisk is studying semaglutide, also known as Wegovy and Ozempic, in a
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  for treating MASH. 
• Eli Lilly released positive mid-stage data on tirzepatide, also known as Zepbound and Mounjaro, in treating MASH, and expects to present full data from that trial later this year. 
• Zealand Pharma and Boehringer Ingelheim released positive mid-stage data on an experimental ***** called survodutide in MASH patients. The companies are also studying the treatment in late-stage trials as a treatment for obesity. The treatment activates GLP-1 and another hormone called glucagon. 
• Merck is studying a ***** called
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  in mid-stage trials. The treatment activates GLP-1 and another hormone called glucagon. 

Mizuho healthcare equity strategist Jared Holz wrote in an email to investors Friday that GLP-1 uptake is one factor that will be “key regarding the broader NASH thesis.” 

He said that’s because “there is no doubt in our minds that the use of the weight-loss therapies will greatly reduce liver **** and would expect many doctors (at least primary care) to opt for GLPs first, before referring patients to specialists.”

Wegovy, Ozempic, Zepbound and Mounjaro are already pricey at around $1,000 per month, or around $13,000 annually, before insurance and other rebates. But that’s still far less than the nearly $50,000 annual price tag of Madrigal’s *****. 

We’ll likely have a better idea of what the MASH ***** landscape will look like over the next year – and how big a threat GLP-1s will be – so stay tuned for our coverage!

Feel free to send any tips, suggestions, story ideas and data to Annika at

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Latest in health-care technology

Takeaways from the HIMSS conference 

Attendees at HIMSS in Orlando, Florida 2024.

Courtesy of HIMSS

Perhaps unsurprisingly, generative artificial intelligence dominated my conversations at the HIMSS conference in Orlando, Florida last week. 

As I raced across the exhibition floor to meet with executives from companies like

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,

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, Epic Systems, GE HealthCare, Salesforce and more, the topic was quite literally hard to avoid. I walked by a random sample of around 40 vendors at the conference, for instance, and about 75% of them had the word “AI” displayed prominently on their booths. 

AI’s popularity at HIMSS was expected. As I mentioned in last week’s newsletter, it stole the show at last year’s conference, too. But this year, the conversation around the role of AI in health care had matured. Instead of discussing long-term, far-reaching applications of the technology, most of my conversations were about how it is being tested and used in practice. 

The most popular use case by far was ambient clinical documentation, which came up over and over again. Ambient clinical documentation tools allow doctors to consensually record their visits with patients, and those conversations are automatically transformed into clinical notes and summaries using AI. 

Companies like

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’s Nuance Communications, Abridge and Suki have developed these capabilities, which they argue will help reduce doctors’ administrative workloads and prioritize meaningful connections with patients. 

Administrative tasks are a major problem for doctors across the U.S. health-care system, as they are one of the primary drivers of burnout, according to a survey published by Athenahealth in February. As a result, health systems have a lot of interest in tools like ambient clinical documentation that could help reduce this clerical burden. 

Organizations like Stanford Health Care and California-based UCI Health announced at HIMSS that they are rolling out ambient clinical documentation tools across their entire enterprises. Since automating documentation does not directly impact patients’ diagnoses or care, I expect we’ll see lots of similar announcements across the country this year. It’s an easier, less risky way for health systems to deploy generative AI at scale. 

Many of the companies I spoke with are dipping their toes into more patient-facing and diagnostic AI applications, but I think it will be a while before we see doctors and nurses widely using the technology to support their treatment decisions. 

Feel free to send any tips, suggestions, story ideas and data to Ashley at

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Biotech and Pharmaceuticals,Health care industry,Merck & Co Inc,Zealand Pharma A/S,Zealand Pharma A/S,Madrigal Pharmaceuticals Inc,Science,******* States,Akero Therapeutics Inc,Viking Therapeutics Inc,Aligos Therapeutics Inc,Eli Lilly and Co,Novo Nordisk A/S,Novo Nordisk A/S,89Bio Inc,

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#NASH #liver #******** #***** #coming

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