Latest / GLP-1 Newspaper: Daily Ozempic, Zepbound & Weight-Loss Drug News / EU Regulators Back Lilly's Foundayo Pill for Weight Loss and Type 2 Diabetes

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EU Regulators Back Lilly's Foundayo Pill for Weight Loss and Type 2 Diabetes · GLP-1 Newspaper: Daily Ozempic, Zepbound & Weight-Loss Drug News

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  Welcome to the GLP-1 Newspaper, your daily update
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  on the news shaping GLP-1 and weight loss medications.
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  Visit glp1newspaper.com to see today's stories
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  and sign up for email alerts. Okay, let's unpack
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  this because today we are looking at a major
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  regulatory milestone over in Europe. Yeah, a
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  massive one. Right, and it's one that signals
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  a huge shift in the GLP-1 landscape. We're talking
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  about the European Medicines Agency, their key
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  scientific committee. just backed Eli Lilly's
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  once-daily pill, Foundayo. Or chemically known
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  as orforglipron. Exactly. And they backed it
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  for both weight management and type 2 diabetes.
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  Which, you know, when you think about it, this
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  proves the whole battleground for these medications
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  is moving. It really is. I mean, for the last
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  few years, this has been an American injection
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  race, right? Everyone has been focused on the
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  pens and the syringes. But this proves we are
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  officially moving into a global pill race. A
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  global pill race. I like that. Well, it's true.
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  But the thing about Europe is it also highlights
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  this incredibly complex road from getting an
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  agency recommendation to, you know, actual patients
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  being able to pick it up at their pharmacy. Yeah,
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  the access side of things. So let's establish
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  what actually happened first. What exactly did
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  the EU regulator do here? So the specific group
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  we're talking about is the CHMP. That's the Committee
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  for Medicinal Products for Human Use. Right.
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  The Scientific Gatekeepers. Exactly. They act
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  as the gatekeepers for the European Medicines
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  Agency, and they just issued a positive recommendation
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  for Foundayo for a dual indication. And the first
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  one is for weight management, right? Yes, weight
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  management. And the criteria they laid out follow
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  the standard guidelines we usually see. So they
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  recommended it for adults with a BMI of 30 or
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  higher, which classifies as obesity. Or a BMI
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  of 27 to under 30, right? As long as there's
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  a comorbidity. Precisely. If they are in that
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  overweight category, starting at a 27 BMI, they
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  need to have at least one weight-related comorbidity.
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  And the agency actually listed those out specifically.
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  What were they? They included prediabetes, type
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  2 diabetes, hypertension, dyslipidemia, obstructive
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  sleep apnea, or cardiovascular disease. Okay,
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  so that's a pretty comprehensive list for the
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  weight management side. What about the type 2
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  diabetes indication? For type 2 diabetes, it's
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  recommended to be used alongside diet and exercise,
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  which is standard, but it can be used either
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  alone as a standalone treatment when metformin
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  isn't appropriate or combined with other existing
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  diabetes medications. Okay, so what does this
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  all mean for the timeline? Because a recommendation
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  sounds great, but is this an outright approval?
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  Like, does this put the pill on pharmacy shelves
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  in Paris tomorrow? No, no, it definitely doesn't.
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  And that's a key distinction in the European
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  regulatory process. The CHMP recommendation is
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  a vital intermediate step. Oh, intermediate.
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  Right. It now has to go to the European Commission.
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  The Commission is the body that actually issues
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  the final EU-wide marketing authorization. But
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  they usually agree with the CHMP, don't they?
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  They do. Yeah. They typically follow the committee's
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  scientific advice, and we usually see that final
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  approval come through within a few weeks of the
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  recommendation. Okay, so we're weeks away from
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  the official stamp of approval. But to even get
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  that positive recommendation, Lilly had to bring
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  a ton of clinical data to the table. Oh, a mountain
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  of data. Let's talk about the evidence driving
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  this. Let's start with the weight management
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  trials. Sure. So the weight management nod stems
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  from two really massive studies involving over
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  4 ,740 adults. That's a huge trial. It is. And
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  the results over a 72-week period showed that
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  patients taking Foundayo lost between 5% and 11
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  % of their body weight, depending on the dose
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  they received. Wow. And the placebo group? The
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  patients on a dummy pill doing the same diet
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  and exercise counseling, they only lost about
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  2% to 2.5%. So, yeah, 11% compared to just
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  over 2%. That is a massive difference. It really
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  is a clinically significant reduction. And the
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  diabetes data is just as strong, right? Absolutely.
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  The type 2 diabetes recommendation is backed
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  by four main studies with 3 ,765 adults. And
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  in those trials, Foundayo reduced A1C levels,
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  which is that key blood glucose marker we always
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  look at, by 1.2 to 1.9 percentage points. That's
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  a big drop. It is, especially when you consider
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  the placebo drop was only 0.4 to 0.8 points.
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  But what's really important here is that Lilly
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  didn't just test this against a placebo. Right,
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  they went head to head with the competition.
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  which is always my favorite part of these studies.
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  It's like, you know, it's one thing to run a
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  race by yourself to see if you're fast, but it's
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  totally different to actually line up against
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  the reigning track champions and see if you can
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  pull ahead. That's exactly what they did. And
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  they came out on top. They tested Foundayo against
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  Dapagliflozin, and Dapagliflozin only had a 0.8
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  point A1C drop compared to Foundayo's 1.2
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  to 1.9. Wow. That's a decisive win. It is. And
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  they even tested it against Novo Nordisk's oral
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  semaglutide. They looked at the 7 milligram and
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  14 milligram doses of that, which produced a
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  1.2 to 1.5 point drop. So oral semaglutide
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  maxed out at a 1.5 drop, but Foundayo reached
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  up to 1.9. Exactly. Though I should mention,
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  reaching that 1.9 point reduction requires getting
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  patients up to the higher doses. Foundayo treatment
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  involves starting at a low dose and gradually
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  increasing through six available strengths. Six
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  different strengths. That sounds like a lot of
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  titration. It ranges from 0.8 milligrams all
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  the way up to 17.2 milligrams. And that gradual
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  increase is entirely designed to manage the side
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  effects, which, as with all GLP-1s, are primarily
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  gastrointestinal. Right, the nausea, vomiting,
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  diarrhea. The usual suspects. Exactly. But stepping
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  up slowly allows those side effects to lessen
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  over time as the body adjusts. Okay, so the data
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  is incredibly solid. But I want to pivot to the
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  molecule itself. Because having a pill is one
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  thing. But from my understanding, the physical
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  design of this specific drug is what makes it
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  such a competitive juggernaut. You've hit the
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  nail on the head. Foundayo, orforglipron, is
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  a non-peptide, small-molecule GLP-1 receptor
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  agonist. Non-peptide. Right. And what's fascinating
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  here is that traditional GLP-1s are peptides.
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  They are basically chains of amino acids. And
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  human stomachs are incredibly efficient at destroying
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  peptides with acid and enzymes before they can
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  ever reach the bloodstream. Which is why we've
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  had to inject them for so long. Precisely. Now,
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  other oral GLP-1s like Novo's Wegovy pill and
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  their ribelsis pill, they use a peptide but pair
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  it with a protective compound to sneak it through
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  the stomach. But that comes with a ton of rules,
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  doesn't it? It does. It comes with very strict
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  administration rules. But because Foundayo is
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  a small, non-peptide molecule, it doesn't need
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  that protection. It survives the stomach just
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  fine on its own. So it completely bypasses those
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  rules. Entirely. It can be taken at any time
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  of day, with or without food, and without any
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  water restrictions. Okay, here's where it gets
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  really interesting for me. And I want to push
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  back on this a little bit. Does a simple rule
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  like, you know, take your pill with water on
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  an empty stomach really matter that much? Is
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  convenience just a luxury here or is this a true
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  medical advantage? It is absolutely a medical
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  advantage. When we are dealing with chronic disease
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  management, convenience equals compliance. Convenience
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  equals compliance. Yes. Think about the current
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  oral GLP-1s. You have to wake up, take it on
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  an empty stomach with exactly up to four ounces
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  of water, and then wait 30 minutes before you
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  can eat, drink, or take other meds. Right, before
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  you can even have your morning coffee. Exactly.
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  And for shift workers or parents rushing to get
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  kids to school, that 30 minute window is a massive
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  barrier. If they forget or they accidentally
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  have breakfast first, their dose for the day
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  is ruined. Oh, I see. So it's not just annoying.
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  It actually stops the drug from working properly
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  if you mess up the routine. Exactly. And early
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  U.S. prescription data really highlights this
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  because pills with any time dosing are actively
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  expanding the market. Expanding it, not just
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  stealing patients from injections. Right. They
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  are attracting patients who were entirely reluctant
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  to use injections, but who also didn't want to
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  deal with those rigid dosing regimens of the
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  older pills. Which brings us to the global race,
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  I think, because this market is expected to surpass
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  $100 billion by 2030, right? It is. And Lilly
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  and Novo are no longer just fighting with their
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  injectables, you know, Mounjaro and Zepbound versus
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  Wegovy and Ozempic. They are opening a brand
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  new front with these pills. And the U.S. launch
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  race is already underway. Foundayo launched in
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  the U.S. back in April 2026. And I saw it generated
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  like $98 million by the second quarter. Yeah.
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  And it hit the U.K. in August. Now Lilly is
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  seeking approval in roughly 40 different countries.
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  40 countries. Wow. OK. That is a truly global
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  expansion. It is. But I do think we need to bring
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  a sobering reality check to this, especially
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  regarding Europe. OK. Because of how their health
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  system works. Exactly. While we expect the European
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  Commission's final nod in a few weeks, that does
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  not mean immediate access for patients across
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  Europe. Right. Because unlike the U.S., where
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  the FDA approves a drug and it basically goes
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  to market, Europe is totally decentralized. It
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  is incredibly fragmented. Once the EU grants
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  that market authorization for safety and efficacy,
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  the drug faces a second, highly complex battle.
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  The pricing battle. The pricing and reimbursement
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  battle, yes. And that happens at the individual
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  member state level. It is heavily dependent on
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  each individual country's national health system
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  budget and their specific policies. So the actual
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  patient experience is going to vary wildly. Wildly.
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  While the headlines right now are screaming EU
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  approval. The reality for a patient in Paris
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  might look very, very different from the reality
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  of a patient in Berlin or Madrid. Right, depending
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  entirely on how those local health authorities
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  negotiate the price. Exactly. Germany might negotiate
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  one rate and get it on shelves in a few months,
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  while Spain might take over a year to agree on
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  reimbursement terms. That's a really important
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  distinction for people following this news. It's
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  a huge milestone, but the commercial reality
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  is still going to be a massive hurdle. It is.
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  But if we zoom out for a second, I think this
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  shift is just incredible. If non-peptide molecules
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  successfully strip away the hurdles of injections
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  and they get rid of these strict fasting requirements,
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  we are looking at a fundamentally different future.
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  A future where taking a powerful metabolic regulator
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  is just an everyday thing. Right. They could
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  become as routinely prescribed and casually integrated
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  into morning routines as statins or even daily
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  vitamins. Wow. Yeah. When you put it like that,
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  it really changes the scale of things. It leaves
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  you with a pretty profound thought, I think.
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  How will society's entire view of obesity and
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  metabolic disease change when the treatment is
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  as simple and painless as taking an aspirin?
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  That is a fascinating question to end on. Thanks
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  for listening to the GLP-1 Newspaper. This show
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  is for information only and is not medical advice,
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  so always talk to your doctor before starting,
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  stopping, or changing any medication. Visit glp1newspaper.com
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