Expert Discusses The Future of GLP-1 Medication, Expanded Indications

James Shehan, JD, chair of FDA Regulatory Practice at Lowenstein Sandler, discusses the stigma around obesity and how evolving views of it as a chronic condition could impact approval and coverage of anti-obesity medications. He also explores promising new research directions like potential neuropsychiatric indications and forecasts that established players like Novo Nordisk and Lilly will continue leading innovation, though competition from additional market entrants may drive further treatment options.

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Q: What could the future of the competitive market in GLP-1 medications look like? What can we expect moving forward?

James Shehan: It's interesting because Novo Nordisk and Lilly have a huge advantage because they're the established players on the market, and everyone else seems to be significantly behind whereas Lilly and Novo Nordisk aren't resting on their laurels, they are tracking down all kinds of new leads, new compounds, new uses for the products. On the other hand, you have some of the big players in the industry, as well as smaller companies, all joining in, so I think you'll get some intriguing results out of that. But to a certain level, these markets get saturated. If you have 10 molecules that are doing the same thing, people very soon focus on the best couple out of those, like Lipitor for controlling cholesterol. So I think there's gonna be a lot of activity, but unless someone comes through with something that's really different, or is treating a different indication are much more effective, fewer side effects. It's going to be hard to assail the lead of Lilly and Nova Lourdes. Now, here's an interesting piece of data. I think it was in 2023. The sales of Ozempic/Wegovy, so one molecule plus Humira, in the United States were more than the sales of the entire generic drug industry of like 1100 or 1300 compounds.

Q: What are the current or potential regulatory hurdles that GLP-1 and weight-related medication face?

James Shehan: The Medicare aspect is interesting, but you've seen in the last couple of weeks Medicare opening the door, saying that, for the example of semaglutide and the cardiac indication that now it can be covered by Medicare. You may see continued pressure to say that as data keeps piling up, that weight loss is not just a cosmetic good, but has a overall health benefit. You could see Medicare eventually just saying, 'Well, I guess we'll cover this.' But the cost implications are huge. On the otherhand, you've already had the government coming out and saying that they will start the Inflation Reduction Act type negotiations for semaglutide as soon as the law permits it, which is I think is like 2028 or 2029.

Q: How has the stigma around obesity as a lifestyle "choic impacted the approval or potential approval of these medications?

James Shehan: I think the FDA, they clearly see it's not a cosmetic issue. It's a health issue. So, for the regulators that factor has kind of dropped out of the picture. I think it still persists, maybe at CMS, Congress, in the public at large, but you've seen some changes there. People are, I think, much more willing to understand that obesity is least is something that is least only partially in control of an individual.

Q: Moving forward, how can the acceptance and acknowledgement of obesity as a chronic condition affect the potential approval and uptake of weight-related medications?

James Shehan: I think that's almost a self answering question. If people come to see that you're overweight, and you can take a drug and it's more something that like high blood pressure, that will [impact] broader uptake of these products, assuming that they're affordable for people to take.

Q: Is there anything else you would like to add?

James Shehan: These are a very exciting class of drugs, and I started working with these products in 1993, within a couple of weeks of joining Novo Nordisk, and we still don't know their full potential, which is kind of remarkable. So I think it's going to be something that is going to be woven into the fabric of society with lots of intriguing developments coming up in the next 5 to 10 years.