by Matt Weik, BS, CSCS, CPT, CSN
GLP-1 has been a massive topic this year, and I feel as if things are only getting started. With the talk of a GLP-1 pill on the horizon, it makes me wonder how this will change (if anything) in the U.S.
There’s no denying the fact that we have an obesity epidemic on our hands in America. People eat junk, don’t get enough movement throughout the day, and our lifestyles seem to be getting more sedentary with each passing year.
So, could a GLP-1 pill change things?
I’ve had clients come up to me and ask my thoughts on GLP-1 medication. While my response may not be what they wanted to hear, it’s not going to change the fact that Big Pharma will continue to pump out similar drugs.
All that being said, Eli Lilly’s experimental GLP-1 pill, orforglipron, could receive FDA approval sooner than expected thanks to a new fast-track review program.
Typically, the FDA takes about 10 months to review a new drug application. But under this new program, certain drugs could be approved in as little as one to two months. Analysts believe orforglipron is a strong candidate, especially given the financial burden of today’s injectable GLP-1 drugs and the push to expand U.S. manufacturing.
Lilly hasn’t confirmed whether the pill will go through this new pathway, but the company called the FDA initiative “a promising development.”
Personally, I don’t like any drug being fast-tracked as it doesn’t provide enough time to gather enough data on potential side effects (both short- and long-term).
But in this article, we are going to take a deeper dive into the potential for a GLP-1 pill and how all of this is moving forward.
Disclaimer: This article is for informational purposes only and should not be used to treat or diagnose any condition. It is recommended that you speak with your doctor before starting any exercise program, making changes to your nutrition plan, or adding any new supplements into your current regimen.
A GLP-1 Pill Could Be a Less Expensive Option
GLP-1 injections like Lilly’s Mounjaro and Zepbound (or Novo Nordisk’s Ozempic and Wegovy) are insanely popular. Look at all the celebrities who have jumped on board with it. Heck, even look around you in your family and neighborhoods. The number of people who have and are using it is wild.
But the one thing that many people complain about is that they come with a hefty price tag. Lilly’s injectable treatments cost nearly $8,000 per year, making them difficult for many people on a budget to afford. Employers and insurers are already pushing back, calling these costs unsustainable.
A GLP-1 pill could completely change the dynamic and pricing structure.
Analysts from Jefferies and Citi Research believe orforglipron is an ideal candidate for the FDA’s new program because it addresses a major health burden (obesity) while potentially offering more affordable pricing without causing people to consider selling a kidney in order to afford it.
Goldman Sachs even projected that if the pill launches one quarter earlier than expected, it could generate an additional $1 billion in revenue for Lilly.
What Makes Orforglipron Different?
Unlike Novo Nordisk’s experimental GLP-1 pill (which is peptide-based and more complex to produce), Lilly’s orforglipron is a synthetic drug. That difference could give Lilly more flexibility in pricing, which may help it compete in a crowded market.
Recent trial data also supports the excitement. In one study, patients taking orforglipron lost 12.4% of their body weight. The full results are being presented at the European Association for the Study of Diabetes meeting in Vienna.
GLP-1 Pill Market Outlook
The demand for GLP-1 drugs has exploded, with some analysts predicting global sales could hit $150 billion annually by the end of the decade. That kind of growth means competition will be pretty intense.
Goldman Sachs estimates that new GLP-1 pills could cost around $400 a month in the U.S., a considerable difference compared to today’s injectable versions (which can cost hundreds more).
Price competition could play a big role in expanding access and driving market share.
For comparison, the Institute for Clinical and Economic Review estimates that the net price of Lilly’s injectable tirzepatide is around $664 a month. Without insurance, patients can buy it directly from Lilly for $499. A GLP-1 pill at $400 would be a significant step toward affordability.
The FDA’s New Fast-Track Pathway
The FDA’s initiative, called the Commissioner’s National Priority program, is designed to speed up the approval of drugs that meet critical needs. The agency will issue five nontransferable vouchers in 2025 for drugs that fall into one or more of these categories:
- Address a U.S. public health crisis
- Deliver innovation
- Meet a large unmet medical need
- Support domestic drug development and manufacturing
- Improve affordability
Orforglipron checks several of these boxes.
Obesity is a major public health issue, affecting over 40% of adults in the U.S. At the same time, affordability has been a sticking point for GLP-1 treatments. Many people can’t afford monthly injections at current pricing (and I can’t blame them).
A pill that’s easier to manufacture and potentially cheaper could fit perfectly into the FDA’s new goals.
What Are Industry Experts Saying?
Not everyone is surprised by the buzz surrounding Lilly’s GLP-1 pill. Dr. Angela Fitch, past president of the Obesity Medicine Association, said orforglipron could become the first “commodity treatment” for obesity.
She explained that while current medications are priced as specialty drugs, the patient population is too large for that model to be sustainable.
Analysts echo that sentiment. Many believe the pill aligns perfectly with the FDA’s mission to speed innovation, improve access, and lower costs for patients.
What’s Next for Lilly’s GLP-1 Pill
Lilly plans to submit orforglipron for regulatory review later this year (2025).
CEO Dave Ricks recently said the company expects a global launch around this time next year. Meanwhile, Novo Nordisk also has an oral GLP-1 obesity drug under FDA review, with a decision expected in the fourth quarter.
If both pills hit the market, the competition could drive down prices and expand access to millions of patients worldwide.
For now, all eyes are on the FDA and how quickly it moves forward with this new fast-track program. If approved under the initiative, a GLP-1 pill like orforglipron could hit the market much sooner than expected, and potentially reshape the future of obesity treatment.