Raw milk, Wegovy tests, Eisai and Biogen

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A new Wegovy study looks at alcohol consumption

Novo has tested its successful GLP-1 drugs Ozempic and Wegovy in a variety of indications: heart failure, Alzheimer’s disease, metabolic dysfunction-associated liver disease, and now – alcohol-related liver disease.

What’s notable is that in a new Phase 2 trial testing combinations of Wegovy with other drugs in this disease, Novo will investigate alcohol intake as a secondary outcome. (The primary outcome is any change in liver scarring or fibrosis.)

Anecdotes and early academic studies suggest that GLP-1 drugs can curb the use of substances like alcohol, tobacco and possibly even opioids, but pharmaceutical companies have so far shied away from formally studying this.

Read more from me and my colleague Isa Cueto.

Senator investigates Amgen’s lung cancer drug

U.S. Senator Dick Durbin (D-Ill.) accuses Amgen of “putting profits before patients” by continuing to sell a high dose of an expensive cancer treatment even when a lower dose that is less expensive and not as toxic has proven to be , are equally effective.

Durbin sent a letter to Amgen investigating the company’s decision to sell its high-dose drug, Lumakras, for non-small cell lung cancer. The senator said the move “will impose significant costs on patients and American taxpayers,” citing Lumakras’ cost to Medicare in 2022 alone of $124 million.

Read more from STAT’s Ed Silverman.

Leqembi is getting closer to being offered as an injection

Eisai and Biogen said today they have filed with the FDA to sell their Alzheimer’s drug Leqembi through a maintenance-dose auto-injector. This means that patients would first go through an initial phase with the current regimen of IV infusions, but then transition to weekly injections for maintenance.

If approved, this would be a significantly more convenient option for patients, as infusions require patients to travel to a medical facility once every two weeks and receive the infusion over an hour.

But what investors are paying particular attention to is when the companies apply for approval get started patients receiving injections. Maintenance is “nice to have,” but the real focus is on getting shots for induction, “which could increase revenue growth given the convenience factor and reduce healthcare burden,” Jefferies analyst Michael Yee wrote.

The launch of Leqembi, which received full approval last July, was tepid, although it has picked up in recent months as more hospitals set up infusion centers. It brought Biogen first-quarter sales of $19 million, nearly triple the previous quarter’s sales, but still far behind analysts’ earlier forecasts, which suggested the drug would eventually reach billions of dollars a year in sales can generate.

Eisai said in his notes today that Leqembi could generate revenues of $280 million in the US and $360 million globally between the second quarter of 2024 and the first quarter of 2025.

What Leads to Wegovy’s Heart Benefit? Depends on which company you ask

At an obesity conference this week, researchers presented some follow-up analyzes from the pivotal study showing that Wegovy may reduce the risk of cardiovascular complications. Was among them a short analysis that supported the idea that Wegovy’s heart benefits may not be solely due to weight loss.

The data presented in the analysis was quite limited, and an outside researcher I spoke with cautioned against overinterpreting the data. “It appears that there are weight-loss-independent effects, but these data do not rule out the possibility of additional weight-loss-dependent effects,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth.

As more analyzes tease apart the factors behind Wegovy’s heart benefits, it’s worth keeping in mind how these findings factor into each drug company’s arguments about the value of their own anti-obesity drugs.

Novo has put forward the idea that there are weight loss-independent effects that promote Wegovy’s heart benefit. (See this interview with the company’s head of development.) This argument makes Wegovy stand out and suggests that other anti-obesity drugs that use different mechanisms (such as Eli Lilly’s Zepbound) aren’t necessarily helpful for the heart just because they lead to weight loss.

Meanwhile, Lilly supports the idea that much of Wegovy’s heart benefit is due to weight loss. (See this interview with the company’s Chief Scientific Officer.) If this is the case, it could indicate that Zepbound, which appears to lead to more weight loss than Wegovy, could also provide a greater cardiovascular benefit than Wegovy.

We will keep an eye on future analyses. For more on this topic and what science shows us so far, check out this story from last year.

Read more

• My Encounter with the Raw Milk Black Market: Quick, Easy, and Not Controlled by the FDA, STAT
• The White House Raises Tariffs on Chinese Medical Products, STAT
• CVS is ready to dump 10% of its Medicare Advantage members next year, STAT
• What we know about the health effects of extreme heat after the hottest summer on record, STAT