Oral Wegovy Is Headed to the FDA. But It’s Not the 50 mg.
Novo Nordisk just filed their application to the FDA for oral Wegovy, and it’s for the 25 mg dose. Not the 50.
That’s interesting.
Because the 50 mg dose did better in trials. In OASIS 1, it led to a 15.1% average body weight loss and got nearly 85% of people to lose at least 5 percent. That’s massive. The 25 mg dose did well too, still better than placebo, but not quite at that level.
So why not go big?
The answer might be as simple as the supply chain. That 50 mg dose uses a lot more API, and right now, these companies are already scrambling to keep up with demand. Starting with the 25 mg dose is probably easier to manufacture, easier to scale, and still very effective.
But it tells you something. Even when a higher dose is on the table, the bottleneck is still access.
Approval expected by the end of 2025. We’ll keep watching.
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You make really good points about the raw material supplies. But, I’m curious, do you think another reason they may be rolling out the lower dose first is because they see a huge profit potential for people who have met their goals on Semaglutide and Tirzepatide wanting the lower dose oral form for long-term maintenance?