Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Good morning. A bunch of my colleagues are traveling to San Francisco (without me) for our Breakthrough West Summit happening tomorrow. If you have FOMO like me, you can still register to get a virtual pass.
And please take a few seconds to fill out our newsletter survey if you haven’t already.
A new Wegovy trial looks at alcohol use
Novo has been testing its blockbuster GLP-1 drugs Ozempic and Wegovy in all sorts of indications: heart failure, Alzheimer’s, 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 be studying 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 may curb the use of substances like alcohol, tobacco, and possibly even opioids, but pharma companies until now have shied away from formally studying this.
Read more from me and my colleague Isa Cueto.
Senator scrutinizes Amgen’s lung cancer drug
U.S. Sen. Dick Durbin (D-Ill.) is accusing Amgen of “putting profits before patients” by continuing to sell a high dose of a pricey cancer treatment even when a lower dose that is less expensive and not as toxic has been found to be similarly effective.
Durbin sent a letter to Amgen probing the company’s decision to sell the high dose of the drug, Lumakras, for non-small cell lung cancer. The senator said this move comes at “at a significant cost to patients and American taxpayers,” citing the $124 million cost of Lumakras to Medicare in 2022 alone.
Read more from STAT’s Ed Silverman.
Leqembi gets closer to being offered as an injection
Eisai and Biogen said today that they’ve filed an application with the FDA to sell their Alzheimer’s drug Leqembi through an autoinjector for maintenance dosing. That means patients would first go through an initiation phase with the current regimen of IV infusions, but then transition into weekly injections for maintenance.
If approved, this would be a significantly more convenient option for patients, since infusions require patients once every two weeks to travel to a medical facility and receive the infusion for an hour.
But what investors are watching out for more is when the companies file for approval to start patients on injections. Maintenance is “a nice to have,” but the real focus is on having injections for induction, “which could ramp sales growth given the convenience factor and reduce healthcare burden,” Jefferies analyst Michael Yee wrote.
The launch of Leqembi, which got full approval last July, has been tepid, though it’s picked up in recent months as more hospitals set up infusion centers. It brought in $19 million in sales for Biogen in the first quarter, nearly triple sales in the previous quarter, but still far short of earlier forecasts by analysts, which suggested the medicine could eventually generate sales of billions of dollars a year.
In guidance today, Eisai today said that Leqembi could bring in sales of $280 million in the U.S. and $360 million worldwide in the second quarter of 2024 to 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 analyses on the pivotal trial that showed Wegovy can cut the risk of cardiovascular complications. Among them was a short analysis that supported the idea that Wegovy’s heart benefits may not be driven solely by weight loss.
The data presented in the analysis were pretty limited, and an outside researcher I talked with warned that the data should not be over-interpreted. “It appears that there are weight loss-independent effects, but these data do not exclude 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 analyses pick apart the factors behind Wegovy’s heart benefits, it’s worth keeping in mind how these findings play into each pharma company’s arguments about the value of their own obesity drugs.
Novo has been pushing the idea that there are weight loss-independent effects that drive Wegovy’s heart benefit. (See this interview with the company’s head of development.) This argument makes Wegovy stand out and suggests that other obesity drugs utilizing different mechanisms (like Eli Lilly’s Zepbound) are not necessarily helpful for the heart just because they lead to weight loss.
Meanwhile, Lilly has supported the idea that much of the heart benefit seen with Wegovy was driven by weight loss. (See this interview with the company’s chief scientific officer.) If this is the case, then that would suggest that Zepbound, which appears to lead to more weight loss than Wegovy, may also offer greater cardiovascular benefit than Wegovy.
We’ll be keeping an eye out for future analyses. For more on this topic, and what the science so far shows us, check out this story from last year.
More reads
- My rendezvous with the raw milk black market: quick, easy, and unchecked by the FDA, STAT
- The White House hikes tariffs on Chinese medical products, STAT
- CVS is willing to dump 10% of its Medicare Advantage members next year, STAT
- What we know about extreme heat’s health impacts after the hottest summer on record, STAT