Image of a healthy liver not ravaged by fatty liver disease.
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Good afternoon! Drugmakers aren’t just racing to develop drugs that treat obesity. They’re also competing to expand the uses of those weight loss treatments, including for a severe form of liver disease.
Some drugmakers — including the dominant players available in the market, Novo Nordisk and Eli Lilly — have already demonstrated the drugs’ ability to assist patients shed unwanted kilos and regulate blood sugar.
Now, they aim to point out the treatments can bring additional health advantages. Doing so could unlock much more revenue from the booming market, and expand the limited insurance coverage for those treatments, most of which cost near $1,000 monthly.
The competition heated up on Monday after Denmark-based drugmaker Zealand Pharma and its partner Boehringer Ingelheim posted strong results from a midstage trial testing its drug, survodutide, in patients with metabolic dysfunction-associated steatohepatitis, or MASH. That condition is characterised by excess fat buildup and inflammation within the liver and might result in liver scarring, or fibrosis.
Survodutide, which helped obese patients or those with obesity lose as much as 19% of their weight in one other phase 2 trial, is just one among a protracted list of medicine that would eventually develop into treatments for MASH.
An update to STAT’s obesity drug tracker on Monday shows that no less than 23 — or about one-fifth — of the 105 weight loss drugs in development or in the marketplace are also being investigated for his or her ability to treat the condition.
So, why are drugmakers specializing in this specific type of liver disease? For one, there are no medicines approved to directly goal MASH. The drugs being tested may not cure the condition, but their reach may very well be large: Around 115 million people worldwide are affected by MASH, and an estimated 3% to five% of U.S. adults have the condition, in response to some studies.
The brand new data underscores the potential for weight loss drugs to assist. As much as 83% of trial participants treated with survodutide saw significant improvements of their disease with no worsening of liver scarring after 48 weeks, compared with 18.2% in a gaggle who received a placebo, in response to Zealand Pharma.
Survodutide also met one among the second goals of the trial, which was showing a “statistically significant” improvement in liver scarring. There have been also no unexpected safety or tolerability issues amongst those that received the drug, even at higher doses.
B. Riley Securities analyst Mayank Mamtani said the information “materially surpassed investor expectations,” and even appears to enhance upon midstage trial data that Eli Lilly released earlier this month.
Around 74% of patients who received the very best dose of Eli Lilly’s drug tirzepatide became freed from MASH with no worsening of liver scarring after a yr. That compares with around 13% of those that received a placebo.
It was less clear how much that drug reduced liver scarring, which was the second aim of the trial. Eli Lilly didn’t disclose whether tirzepatide met that goal, but the corporate said the drug’s effect on decreasing scarring was “clinically meaningful” across all dose sizes.
Nevertheless, Jefferies analysts cautioned in a note Monday that Eli Lilly’s trial included patients with more severe types of liver scarring compared with Zealand Pharma’s study. Which will explain the differences in data.
The 2 drugs work in another way. Zealand Pharma’s treatment mimics a gut hormone called GLP-1, which suppresses appetite, however it also imitates one other hormone called glucagon. Meanwhile, Lilly’s tirzepatide targets GLP-1 and a distinct hormone called GIP.
It’s too early to say whether one drug is higher than one other at treating MASH. It is going to likely take years before we see Eli Lilly and Zealand Pharma’s drugs in the marketplace as a fatty liver disease therapy.
Boehringer Ingelheim told Reuters on Monday that the corporate hopes survodutide will launch as a treatment for MASH or obesity in 2027 or 2028, contingent on favorable trial data.
Full results from each Eli Lilly and Zealand Pharma’s midstage trials will probably be presented at a medical conference this yr. We also must wait for data from other drugmakers: Novo Nordisk is studying semaglutide, also referred to as Wegovy for weight loss and Ozempic for diabetes, in a late-stage trial for treating MASH.
But one biotech company could be the first to bring a successful MASH drug to market: The Food and Drug Administration is slated to come to a decision whether to approve a medicine called resmetirom from Madrigal Pharmaceuticals on March 14.
Latest in health-care technology
Change Healthcare outage rolls into seventh day after cyberattack
Traders work on the post where UnitedHealth Group is traded on the ground of the Recent York Stock Exchange.
Brendan McDermid | Reuters
It has been a rough week for Change Healthcare.
The corporate, which offers solutions for payment and revenue cycle management, said its systems are down for a seventh straight day after parent company UnitedHealth Group disclosed that a “suspected nation-state associated” cybersecurity threat actor gained access to a part of its information technology network last week.
The extent and nature of the breach stays unknown, but UnitedHealth said it isolated and disconnected the affected systems “immediately upon detection” of the threat, in response to a filing with the U.S. Securities and Exchange Commission on Thursday.
The corporate didn’t disclose exactly what Change Healthcare systems the attack disrupted, however the breach has caused problems across health systems and pharmacies at firms resembling CVS Health and Walgreens.
UnitedHealth told CNBC late Monday that greater than 90% of all U.S. pharmacies have arrange modified electronic claims processing workarounds to mitigate the impact of the outage, while the remaining pharmacies have arrange solutions offline.
For consumers resembling Cary Brazeman, the disruption has been a headache.
Brazeman tried to select up a prescription at a Vons pharmacy in Palm Springs, California, on Saturday, but he was told that the pharmacy hadn’t received the transmission from his doctor. Even when the situation had, employees said, they would not have been capable of run his insurance.
“I’m like, ‘OK, what am I presupposed to do now?’ they usually’re like, ‘We do not know,'” Brazeman told CNBC in an interview.
By Monday, Brazeman said the pharmacy had arrange a workaround that helped it communicate with some insurance firms, but not all. He said he is planning to return to his doctor to select up a paper copy of his prescription, bring it back to the pharmacy and hope for the very best.
His immediate concern is not whether his information was compromised, he said, but whether the individuals who actually need medication can access it. Especially patients who’ve conditions more serious than his own.
“I’m mobile, so I could make these rounds if essential, and I will pay money if essential, but there’s a number of individuals who cannot,” he said.
Be happy to send any suggestions, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com and Ashley at ashley.capoot@nbcuni.com
Correction: This story was updated to correct the spelling of Cary Brazeman’s name.
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