“Prepare, Prevent, Respond, Recover.”: Dealing with Drug Shortages

All

right.

So let's start first with two FDA approvals, the first of which is Foundeo, a generic name, or Foraglupron.

Now, this is a small molecule, GLP-1 agonist, that's taken by mouth once daily, which actually makes it unique from the vast majority of existing GLP-1s on the market, which are, of course, injectable.

What also makes it unique is its lack of food, water, and timing restrictions, which differentiates it from oral semaglutide.

It's been approved for weight management based on the results from the ATTAIN-1 trial in which individuals taking the highest dose of Foundeo, which is 17.2 milligrams per day, lost an average of roughly 11% body weight at 72 weeks.

Now, 11% weight loss puts Foundeo kind of right in the middle of the pack.

So it's overshadowed by Wegovi High Dose and Zepbound, which boast roughly 20%.

However, its hassle-free oral administration may actually make this an appealing option to some patients.

I will note that Foundeo is already commercially available and a type 2 diabetes indication is expected later this year.

I was just going

to say, Chris, real quick, sorry to interrupt, as we've charted on this show now for years, just the evolution of these drugs just continues to amaze, especially with the oral options.

Yeah.

And expect more.

Obviously, it's kind of like a shtick at this point, but expect more to come.

I mean, literally before recording this episode a couple of days ago, Rattatratai just came out with their top line results, like 28 percent body weight loss.

It's just insane.

So I think we're only going to continue to see more and more of these as time goes on.

And it seems like it's quicker and quicker than what we've seen even just like what four or five years ago.

So absolutely.

Yeah.

So then we had a second approval.

This was for Awickley, also known as Generic Insulin Icodec.

Now, this is interesting because it's the first and only once weekly basal insulin that's approved for adults with type 2 diabetes.

Its approval was based on results from the OnWords program in which insulin ICODEC demonstrated non-inferior A1C reduction versus either insulin chlorogene as well as insulin degludec, which are two of the most common basal insulins in use today.

All

right.

So let's start first with two FDA approvals, the first of which is Foundeo, a generic name, or Foraglupron.

Now, this is a small molecule, GLP-1 agonist, that's taken by mouth once daily, which actually makes it unique from the vast majority of existing GLP-1s on the market, which are, of course, injectable.

What also makes it unique is its lack of food, water, and timing restrictions, which differentiates it from oral semaglutide.

It's been approved for weight management based on the results from the ATTAIN-1 trial in which individuals taking the highest dose of Foundeo, which is 17.2 milligrams per day, lost an average of roughly 11% body weight at 72 weeks.

Now, 11% weight loss puts Foundeo kind of right in the middle of the pack.

So it's overshadowed by Wegovi High Dose and Zepbound, which boast roughly 20%.

However, its hassle-free oral administration may actually make this an appealing option to some patients.

I will note that Foundeo is already commercially available and a type 2 diabetes indication is expected later this year.

I was just going

to say, Chris, real quick, sorry to interrupt, as we've charted on this show now for years, just the evolution of these drugs just continues to amaze, especially with the oral options.

Yeah.

And expect more.

Obviously, it's kind of like a shtick at this point, but expect more to come.

I mean, literally before recording this episode a couple of days ago, Rattatratai just came out with their top line results, like 28 percent body weight loss.

It's just insane.

So I think we're only going to continue to see more and more of these as time goes on.

And it seems like it's quicker and quicker than what we've seen even just like what four or five years ago.

So absolutely.

Yeah.

So then we had a second approval.

This was for Awickley, also known as Generic Insulin Icodec.

Now, this is interesting because it's the first and only once weekly basal insulin that's approved for adults with type 2 diabetes.

Its approval was based on results from the OnWords program in which insulin ICODEC demonstrated non-inferior A1C reduction versus either insulin chlorogene as well as insulin degludec, which are two of the most common basal insulins in use today.