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Weight-loss data positions Eli Lilly’s tirzepatide for 2023 obesity approval

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Eli Lilly says its incretin drug tirzepatide is on track for approval in obesity later this year, following release of Phase 3 results which solidify its weight-loss profile.

Lilly announced data from its SURMOUNT-2 study of tirzepatide in obese diabetics Thursday, with the study showing about 16% weight loss. That equates to more than 34 pounds over nearly 17 months, the company said.

Weight loss in this late-stage study was expected to fall below the 21% seen in the earlier SURMOUNT-1 study, which included similar subjects without diabetes. Following the trial, Lilly said it will complete an application to the Food and Drug Administration for fast-track approval of tirzepatide in obesity over the coming weeks. Regulatory approval is expected by year’s end.

“We believe addressing obesity could make an enormous difference in millions of people’s lives, significantly impact public health and reduce health care costs,” Lilly CEO David Ricks said during a Thursday afternoon call to review the company’s first-quarter results, released yesterday as well. “We are encouraged by this important next step in the journey to redefine obesity care.”

FDA awarded tirzepatide fast-track designation last fall which, in addition to a rolling submission, should help to expedite the review. However, Lilly isn’t taking chances. It’s using a priority review voucher (PRV), which shaves four months from the review time.

“While we think the FDA will act quickly with the fast-track designation, we want to remove any uncertainty,” explained Mike Mason, president of Lilly Diabetes, during the earnings call. “We will be using a PRV and expect that we’ll get approval as early as the end of this year.”

The company’s obesity filing in the EU is already complete and approval there is expected in the first half of next year.

Tirzepatide, approved to treat type 2 diabetes under the brand name Mounjaro and launched in Q2 2022, was also a highlight of the quarter. Mounjaro generated sales of $569 million, beating Wall Street’s consensus by $135 million. The drug’s access picture improved, with roughly 55% of scripts reimbursed in the quarter versus 40% in the last three months of 2022.

Mounjaro sales are forecast to hit $3.7 billion this year, increasing to $8.1 billion in 2024, according to an estimate by J.P. Morgan Chase. Meanwhile, the company’s total incretin franchise is projected to reach nearly $40 billion by the mid-2030s.

“With unprecedented demand for the GLP-1 category, we expect production capacity to be a key gating factor for sales growth,” JPM’s Chris Schott wrote in a note to investors Thursday.

To that end, the company’s new manufacturing facility in North Carolina, set to double capacity, is coming on-line later this year and should help in that regard. Intermittent shortages, compounded by widespread off-label use, have made Mounjaro and other drugs in the GLP-1 class – namely Novo Nordisk’s Ozempic – hard to get.

Lilly would not confirm whether tirzepatide will be marketed for weight loss in the U.S. under a different brand name, similar to the way Novo splits branding for Wegovy and Ozempic, intended for obesity and diabetes, respectively.

Some analysts think the company is leaning toward distinct branding. Asked about the pros and cons of each, Mason cited the two-brand scenario’s “access benefits” and the ability to have “an empty vessel” for the unique promotion of an obesity indication. Merging the two makes for a more efficient supply chain and manufacturing.

Due to unforeseen high product demand and short-term manufacturing issues, Novo faced supply constraints for Wegovy that disrupted its launch. The Danish company said earlier this year that all dosage strengths of Wegovy were back in stock, which allowed the resumption of commercial activity.

“There’s just a tremendous unmet need in the obesity market,” said Mason, adding, “We’re not surprised by Wegovy’s uptake after the resupply and relaunch.”

 

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Optimal routine

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Optimal routine is backed with a 60 Day No Questions Asked Money Back Guarantee. If within the first 60 days of receipt you are not satisfied with Wake Up Lean™, you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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Clickbank Backup

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Clickbank Nourished Mamas Guide to Postpartum | Birth Education Class in Holland

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Product Name: Clickbank Nourished Mamas Guide to Postpartum | Birth Education Class in Holland

Click here to get Clickbank Nourished Mamas Guide to Postpartum | Birth Education Class in Holland at discounted price while it’s still available…

 

 

Don’t let exhaustion be the reason you neglect yourself postpartum.

Newborns are a LOT of work. You don’t have time for more research. Make self-care simple by allowing our 23 years of education and experience to be your step-by-step guide to nourished motherhood.

Learn what’s “normal” to experience as a new mom.

With a total of 13 years of experience as moms ourselves, we understand the challenges of motherhood. Whether it’s diastasis recti, prolapse, low libido, always feeling exhausted, or being disconnected from everyone around you-our guide can help. This guide will teach you how to confidently navigate the many unknowns of motherhood.

Are you feeling the pressure of “bouncing back” after pregnancy?

Fitting back into your pre-pregnancy jeans STARTS with adequately nourishing your body and following safe exercise plans. Our guide will provide both!

Supplements, recipes, safe weekly exercises- this guide covers it all.

You’ll learn how to balance your hormones, replenish your depleted nutrients, strengthen your core and pelvic floor, and be pain-free with just this ONE guide.

Costs less than 1/4 of what 1 on 1 services would cost.

Keeping it simple allows you to be successful!

Each week you can open up your guide (digital or printed copy) and spend a quick 10-15 minutes learning about what you’ll be doing for the week to nourish and heal your postpartum body.

It’s easy to go on YouTube and find postpartum “safe” exercises. You can simply order and experiment with your favorite influencer’s supplement suggestions.  Pinterest is full of “healthy” postpartum recipes. BUT are those really SAFE and HEALTHY suggestions that will work for YOU postpartum.

THIS guide was not made by a Physical Therapist that added in her favorite recipes or a Hormone Coach that suggested a few exercises she enjoyed doing postpartum. NO!! THIS guide was made by two different experts that combined forces to create a COMPLETE STEP-BY-STEP GUIDE for your first 6 weeks postpartum.  We truly considered all of your needs-physical and emotional.

Our hope is that you’ll feel energized, strong, hormonally balanced and truly supported as a whole person after completing this program.  Your body is working incredibly hard.  You deserve the opportunity to be a Nourished Mama!

Weekly exercises designed specifically for newly postpartum moms (including those with diastasis recti and prolapse).

Toxin-free product recommendations for mom and baby including supplements, supplies, and holistic remedies.

Recipes and specific food brand recommendations to support depleted postpartum nutrients.

Ways to identify red flags indicating that your body is NOT healing as it should be.

Care tips for perineal trauma, cesarean incisions, clogged ducts, and utilizing your support system.

Checklists, resources, products, healthy and safe ways to move are all included in this simple to follow week-by-week guide.

Freezer meal ideas with nourishing ingredients for healing.  A mental health checklist to prepare for postpartum. Suggestions for plastic free pumping and milk storage supplies.  A list of toxin-free postpartum must-haves. Tips for avoiding and managing postpartum constipation. Recommendations for supplies to include in your postpartum nesting space.

Recommendations for how much out of bed activity to do your first week postpartum. Your first two gentle strengthening exercises and a simple stretching activity.  Ways to stay comfortable if you experienced perineal trauma.  Healing strategies for those who have had cesarean deliveries.

Suggestions for gradually increasing your out of bed time this week.  Several more early postpartum exercises along with stretches to avoid back pain.  Feeding position recommendations to avoid pain or to improve latch and emptying if you’re breastfeeding.

Nourishment guidance including an example schedule of what and when to eat.  Tips for interpreting your postpartum bleeding.  New strengthening exercises and two new stretches. A mental health check-in and ideas for maintaining connection in your relationships.  Ways to identify if you’re going to need pelvic floor physical therapy because of perineal trauma.  How to avoid scar tissue around your cesarean incision.

Learn about how to keep your body safe while baby wearing and walking for exercise. We’ll turn up the heat on your workouts just slightly this week and introduce you to some stretches to keep your pelvic floor happy. This week you’ll be introduced to desensitization for cesarean scars.

Explore ways to improve sleep, improve energy, and balance hormones and minerals postpartum. Learn about your postpartum menstrual cycle and safe period products. Identify helpful questions to ask your provider at your postpartum follow-up. Challenge your body’s strength with three full workouts for the week along with activities to keep you stretched and pain-free.

Our version of the “sex talk” is on the agenda for this week including lubricant recommendations, symptoms of abnormal pain, and understanding your libido. Those with incisions will learn how to breakdown perineal scar tissue and adhesions on cesarean incisions. Once again, plan on completing three full workouts this week.

All exercises include links and QR codes to video demonstrations with cues to engage your core and pelvic floor.

Breakfast, lunch, dinner, snack & dessert recipes all included. 70 pages of simple meals ideas to keep you and your family nourished.

Discount codes for all of our favorites! Pelvic floor tools, menstrual products, supplements and more. All the products we use, recommend, and love.

“The Nourished Mama’s Guide to Postpartum is an incredible way to guide you through your postpartum journey. I wish I would have had this guide after my first born but it served me well after my second born! I had an emergency c-section, and the guide helped me build confidence by strengthening my physical and mental well-being.”

“I definitely align with this and think it’s super valuable information for every mama to have. And I need these strengthening exercises big time! I also love how you have both perineal & c-section care together. Meets every birth experience right where they are.”

Step-by-step 6 week postpartum program to restore your energy, get you stronger, and maintain hormone and mineral balance in your body after pregnancy.

I’m very familiar with feeling broken, overwhelmed, and completely unprepared at a time when I’m “supposed” to be falling in love with my new baby.

Most people know me as a Pelvic Floor Physical Therapist sharing motherhood tips and hacks on my YouTube channel, Doctor Nicole. But I haven’t always had all the answers.

After the birth of my first son my body was a mess. Because of an unexpected episiotomy, I couldn’t sit on regular chairs for weeks and intercourse was downright impossible. Add on a giant pregnant belly that had turned into diastasis recti postpartum, and you’ve got yourself a hot mess.

I know what it’s like to feel mom-guilt. I’m supposed to enjoy being a new mom, BUT all I can think about is how I still look pregnant and I may never have an orgasm again.

But now I’m blessed to be running around the beach with my 3 boys and enjoying my time in the bedroom more than ever before. I’m proof that your body doesn’t have to stay broken after having babies.

Over the past 5 years, I have worked with hundreds of in-person clients to reclaim their postpartum bodies and now women around the world are finding hormonal balance, core strength and joy within 6 weeks of having their babies by…

Discovering the secret to abandoning brokenness and feeling good in their own skin again!

After struggling with her own imbalances that appeared as acne and migraines in her teens and trying all of the mainstream fixes, she started to do her own research.  She found that everything we put in and on our body matters, and that exercise not only strengthens the body but has a huge effect on our stress and detoxification pathways. As she started to see improvements in her own health, she became passionate about sharing her experience with others so that they wouldn’t have to be stuck in the pattern of “normal” that is so far from abundant wellness.

After purchasing this guide, you will immediately be directed to a thank you page that will walk you through how to login and download your electronic version of the guide.  We’ll also send you a confirmation email to be sure you were able to access your guide. (If you don’t see it within 5 minutes, check your SPAM for an email from Doctor Nicole.) Once downloaded, the guide is yours to keep and access on your computer or from your phone for as long as you need it. Your printed version of the guide arrives within 6-12 days of ordering, depending on what country you live in! A tracking number is provided once your order has shipped.

Yes, we will provide you with a downloadable and printable version of this guide.  The printed version will include QR codes to easily access the exercise video demonstrations.  The downloadable version will include direct links to those same videos + many additional products. As a BONUS, we will also print and ship a perfect bound, color copy of the guide directly to your door.

Whether you are a first time mom or a veteran mom, this course has a lot to offer you.  First time moms will feel confident about navigating the many unfamiliar things that are happening to your bodies as you recover from your pregnancy and delivery.  Veteran moms will learn how to have more energy, more strength, and nourish your bodies with a holistic approach during this recovery.

Since this guide includes a “Postpartum Prep” section, we highly recommend you purchase this guide during your pregnancy. However, if you’ve already had your baby and you’re still in the first 6 months postpartum, there is still LOTS of useful information in this guide. The nourishment recommendations, hormone balancing tips and exercise tutorials are used by clients (and us as guide creators) throughout the first 1-2 years postpartum.

The minute you purchase your guide it will be printed and sent to our shipping team. Shipping takes 4-6 days when being delivered in the U.S. 4-8 days to get to Canada and Europe and 8-12 days to be delivered to Asia and Australia. A tracking number will be sent via email as soon as your order has shipped.

This guide is 160 pages of exercises, recipes, checklists,  and expert guidance that will help you nourish your body physically and mentally during those early weeks postpartum. Your printed version of the guide comes neatly bound as a paperback book.

Includes a 6 week core and pelvic floor strengthening exercise program, over 100 whole food recipes, mental health checklists, and expert recommendations for healing mentally and physically after having your baby.

While social media and diet culture are pressuring new moms to bounce back quickly and get back to doing all the things ASAP, we’re creating a space that’s different.  Being a Nourished Mama means replenishing yourself, resting, fueling your body with quality nutrients, restoring movement, and finding joy in your new identity. Our hope is that after spending 6 weeks postpartum with us, you will feel confident and energized in your role as a mom.

If, for any reason, you aren’t happy with the Nourished Mama’s Guide to Postpartum, contact us and we will refund 100% of your money, no questions asked. Plus you get to keep the guide. No return labels, no trips to the store, and no hassle for you.

Trying out our guide is risk-free! Not 100% satisfied? We’ll give you a full refund anytime within 60 days of your purchase.

ClickBank is the retailer of products on this site. CLICKBANK is a registered trademark of Click Sales, Inc., a Delaware corporation located at 1444 S. Entertainment Ave., Suite 410 Boise, ID 83709, USA and used by permission. ClickBank’s role as a retailer does not constitute an endorsement, approval or review of these products or any claim, statement or opinion used in promotion of these products.

Testimonials, case studies, and examples found on this page are results that have been forwarded to us by users of Mamas & Misses products and related products are not intended to represent or guarantee that anyone will achieve the same or similar results.

For product support, please contact the seller HERE

For order support, please contact ClickBank HERE

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