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Good morning. We’ve got lots of news this morning, so let’s get straight into it.
Pfizer moves forward a daily GLP-1 obesity pill
Pfizer will advance a once-daily formulation of its oral GLP-1 obesity candidate, danuglipron, after facing multiple setbacks in the space.
The company said results from an ongoing pharmacokinetic study led it to choose a formulation to move forward, but did not provide details on the specific formulation. The company will still need to conduct dose optimization studies in the second half of this year.
Investors have been closely watching Pfizer’s work in obesity as the company faces pressure to find new growth generators amid declining sales of its Covid-19 products.
FTC to sue PBMs over high drug costs
The FTC plans to sue the three largest PBMs — Caremark Rx, Express Scripts, and OptumRx — over their negotiating tactics for various medications including insulin, my colleague Ed Silverman reports.
This comes after the agency released a report earlier this week saying that the drug middlemen wield immense power and can significantly affect drug prices.
Ed reports that the lawsuits are expected to focus on the role of rebates. Critics argue that rebates create incentives for PBMs to accept higher prices rather than negotiate lower prices for health insurers and employers.
Novo’s weekly insulin rejected by FDA
The FDA rejected Novo Nordisk’s weekly insulin, as the agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients.
Novo had submitted an application for the insulin, called icodec, for both type 1 and type 2 diabetes patients, but a panel of FDA advisers recently voted against approval of the drug in type 1 patients, raising concerns about the risk of low blood sugar in that population.
Novo said it doesn’t expect to fulfill the FDA’s requests this year. In the meantime, Eli Lilly is also developing a weekly insulin.
Turning on a ‘molecular switch’ to treat lupus
There’s essentially a double disadvantage with lupus: Patients have lower levels of helpful immune cells and higher levels of damage-promoting ones. Cells are able to convert between these two helpful and harmful phenotypes, though, and in a new study, scientists may have discovered a “molecular switch” that can tip the plank in the direction of helpful cells.
The study, published in Nature and led by researchers at Northwestern and Harvard, pinpoint the aryl hydrocarbon receptor, or AHR, as a controller of this seesaw. They found that suppressing AHR led the population of harmful cells to proliferate, while boosting AHR increased the presence of helpful cells.
Existing lupus drugs broadly suppress the immune system, which can be effective but also cause unwanted side effects. New research like this on what precisely causes the disease could guide drug developers toward a more narrow approach.
Read more from my colleague Isa Cueto.
Can you get satiety with GLP-1s without the nausea?
Highly popular GLP-1 drugs like Ozempic and Wegovy can lead to substantial weight loss by suppressing appetite, but they also often cause people to experience the unpleasant and sometimes unbearable side effects of nausea and vomiting. A new study in Nature suggests these the two effects of satiety and aversion are brought about through distinct brain circuits, indicating it may be possible in the future to achieve appetite suppression without the nausea.
A group of researchers led by scientists at the Monell Chemical Senses Center ran mouse experiments to find that activation of NTS GLP-1 neurons triggered satiety without aversive reactions, while activation of AP GLP-1 neurons triggered strong aversion along with a reduction in food intake. The researchers say the findings point to NTS GLP-1 neurons as a possible target to promote weight loss while avoiding the nausea and vomiting.
Scientists are still figuring out how and where GLP-1s act in the brain to lead to weight loss, and the findings of this new study still need to be confirmed in further research. They appear to contradict earlier studies that found that GLP-1 drugs suppress appetite by acting on distributed neural circuits involving the hypothalamus.