Tirzepatide Approved for Sleep Apnea

[bigMoJo]

Looks like the GLPs have made another health breakthrough. This time Tirzepatide has been approved by the FDA for sleep apnea. Zepbound (tirzepatide) manufactured by Ely Lilly will likely gain broader health insurance coverage for the those looking for these medications.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”

FDA Approves First Medication for Obstructive Sleep Apnea

Today, the FDA approved the first medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity.

www.fda.gov

 

[noteablequotable]

And FDA ended the shortage over the weekend. Feel bad for people trying to buy retail.

 

[BigDadd7]

It should help with all those fat necks obstructing air flow

 

[bigMoJo]

And FDA ended the shortage over the weekend. Feel bad for people trying to buy retail.

Feel bad? Likely insurance covers it for most, right? Do you mean for out-of-pocket not getting UGL?

I imagine pharmacies will be busy. There's been a long wait, and this thing is "snow-balling" bigger as it goes. Would you agree another out-of-stock is likely?

I'm going to ask my doctor for a script... I have OSA, but, havn't made the jump on to Tirz yet. I think my insurance covers it, but I'll see what that and the co-pay is... and what the "wait" is.

 

[noteablequotable]

Feel bad? Likely insurance covers it for most, right? Do you mean for out-of-pocket not getting UGL?

I imagine pharmacies will be busy. There's been a long wait, and this thing is "snow-balling" bigger as it goes. Would you agree another out-of-stock is likely?

I'm going to ask my doctor for a script... I have OSA, but, havn't made the jump on to Tirz yet. I think my insurance covers it, but I'll see what that and the co-pay is... and what the "wait" is.

There's a lot that's been happening quietly which is going to make the official stuff more expensive:

1. Some insurance companies dropping coverage
2. Some insurance companies are changing the copay.
3. Lilly has a discount card for people who need to pay out of pocket, but they've steadily decreased the discount rate over time.
4. FDA approval for new uses means increased demand.

I don't think we'll feel the full impact of this until next year because insurance coverage usually starts 01 Jan, but it's definitely coming.

 

[bigMoJo]

Eli Lilly shares are up about 35% this year, and still going.

12/23/2024: "Eli Lilly (LLY) shares added nearly 4% after federal regulators approved its Zepbound weight-loss drug Zepbound to treat sleep apnea."

Lilly Rises on FDA Approval of Weight-Loss Drug-Zepbound for Sleep Apnea

Eli Lilly stock rose Monday after Zepbound received Food and Drug Administration (FDA) approval as a treatment for obstructive sleep apnea among adults with obesity.

www.investopedia.com

 

[Anonymous35]

I had sleep apnea too but i have a CPap machine so i didn’t notice a big difference since i took tirze

 

[Ghoul]

Main reason for seeking approval from the FDA for all these additional indicated conditions , which so far all include "obesity" as a part, ie, heart failure and obesity, sleep apnea and obesity, in which reducing obesity would obviously help, is to get around a law that prevents Medicare (the default insurer for citizens over 65) from covering weight loss drugs,

On another note Sema goes generic worldwide in 2026, except the US where it stays patented until 2030. Chinese UGLs have proven is very cheap to make, so once it goes generic it's going to change the world.

US just turned the corner with obesity rates dropping for the first time, along with longevity starting to increase again after years of dropping.

 

[RandallFlagg]

Main reason for seeking approval from the FDA for all these additional indicated conditions , which so far all include "obesity" as a part, ie, heart failure and obesity, sleep apnea and obesity, in which reducing obesity would obviously help, is to get around a law that prevents Medicare (the default insurer for citizens over 65) from covering weight loss drugs,

On another note Sema goes generic worldwide in 2026, except the US where it stays patented until 2030. Chinese UGLs have proven is very cheap to make, so once it goes generic it's going to change the world.

US just turned the corner with obesity rates dropping for the first time, along with longevity starting to increase again after years of dropping.

Well fuck, can't have that. How we gonna keep up the social security scheme if these fucks keep living beyond retirement age.

 

[bigMoJo]

On another note Sema goes generic worldwide in 2026, except the US where it stays patented until 2030. Chinese UGLs have proven is very cheap to make, so once it goes generic it's going to change the world.

I believe that's what just happened to Victoza. It's an outdated GLP (approved in 2010), but generic was approved by the FDA yesterday.

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

): FDA approved the first generic referencing Victoza, indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type

www.fda.gov

 

[Grey Spartan]

Feel bad? Likely insurance covers it for most, right? Do you mean for out-of-pocket not getting UGL?

I imagine pharmacies will be busy. There's been a long wait, and this thing is "snow-balling" bigger as it goes. Would you agree another out-of-stock is likely?

I'm going to ask my doctor for a script... I have OSA, but, havn't made the jump on to Tirz yet. I think my insurance covers it, but I'll see what that and the co-pay is... and what the "wait" is.

Time for me to hit up the VA. I'm sure I will get the "the government hasn't approved it yet" Uhhhhh isn't the FDA the government? lol

 

[Ghoul]

I believe that's what just happened to Victoza. It's an outdated GLP (approved in 2010), but generic was approved by the FDA yesterday.

FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes

): FDA approved the first generic referencing Victoza, indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type

www.fda.gov

All the generics manufacturers are preparing to produce their versions of Ozempic. It's a fairly lengthy process, since they have to start almost from scratch. The pharma company with the expiring patent doesn't have to share manufacturing techniques, and the generic maker has to demonstrate similar performance, and, as you know is of great interest to me, the same or lower immunogenicity (a monumental task).

The first day the FDA starts accepting applications for generics, all the applicant companies line up at FDA HQ early in the morning, and the first application that meets all the requirements gets a special 6 month head start as the only generic allowed in the market.

The extra profit earned from this 6 month exclusivity period is the "sweetener" to incentivize the research and development cost to develop generics.

 

[Ghoul]

Time for me to hit up the VA. I'm sure I will get the "the government hasn't approved it yet" Uhhhhh isn't the FDA the government? lol

VA covers Zepbound and Wegovy now.

 

[bigMoJo]

as you know is of great interest to me,

Yes, it's definitely interesting, and seems just like following an athlete's or celebrity's career. Can't wait to see what comes of another round of all that massive testing.

 

[Ghoul]

Yes, it's definitely interesting, and seems just like following an athlete's or celebrity's career. Can't wait to see what comes of another round of all that massive testing.

The FDA is preparing for a big wave of generic "biosimilar" protein/peptide drugs, and helping small manufacturers figure out the whole immunogenicity thing has been a major mission over the last few years.

Keep in mind, 50% of new and generic peptides fail to come to market because of immunogenicity.

When people say "this is not a problem", it's because before a peptide goes into human trials. immunogenicity issues either killed it or solutions were found to reduce it to an acceptable level.

It starts with computer simulations that predict every potential way the peptide can degrade, every impurity that can form based on their manufacturing, packaging, and storage method, then predicting how the immune system will respond to every single one of those potential impurities. Epivax is the leader in this tech.

https://www.fda.gov/media/146105/download

UGL "generics" don't go through this process, which is why it's prudent to take charge of the factors we can control ourselves to lower it.