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Kaitlyn Bader is the assistant managing editor of 

 and joined the MJH Life Sciences team in June 2022. She attended Otterbein University in Westerville, Ohio, and earned a Bachelor of Arts degree in literary studies with minors in creative writing and film studies. Prior to health care news, Kaitlyn worked in industrial marketing. She enjoys cooking, reading, and tending to her house plants.

Articles

Catch up on eczema advancements throughout the year, including news on contact dermatitis, chronic hand eczema, and more. 

Spotlighting National Eczema Week 2024 

and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

Lim discusses support for underserved communities, including dermatology training for Pacific Island Nations.

Henry Lim, MD, Shares Insights into ILDS’ DermImpact Grant Program, Support of Underserved Communities

Zoe Diana Draelos, MD, is a consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. She is investigator, Dermatology Consulting Services, High Point, N.C., and a Dermatology Times Editorial Advisor and co-medical editor.

Peptides are increasingly used in cosmeceuticals for their ability to enhance cellular communication and functionality in antiaging formulations.

Answering Your Questions About Cosmeceutical Peptides

Elyse Love, MD, discusses the role of the program in supporting students with skin conditions the financial support and empowerment necessary for academic success.

Q&A: AbbVie Immunology Scholarships Provide Support for Students With Chronic Immune-Mediated Diseases

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Six strategies for profitability with new payment models. 

Embracing Value-Based Care

Organon recently announced that it will acquire Dermavant Sciences

, a Roviant company, and its novel product, tapinarof cream 1% (Vtama). Organon is a global health care company with the mission to “improve the health of women throughout their lives.”

Tapinarof cream 1% is a once-daily, non-steroidal topical that was approved by the FDA for the treatment of mild, moderate, and severe plaque psoriasis in adults in 

 Additionally, the FDA is currently reviewing Dermavant’s 

supplemental new drug application (sNDA) of tapinarof cream

 for the treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older. A Prescription Drug User Fee Act action date is anticipated in the fourth quarter of 2024.

Currently, Organon’s portfolio includes more than 60 medications and products in women’s health, biosimilars, and various therapeutic areas. The company states that it invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars.

"Women were excluded from clinical trials until 1993 when their inclusion became law and for the longest time, many clinical trials ran under the assumption that the only difference between women and men was their sexual and reproductive organs. However, we now understand that many diseases, in particular inflammatory skin diseases, impact women differently. It is known that despite lower PASI scores, psoriasis can have greater negative impacts on quality of life in women in comparison to men," said Mona Shahriari, MD, assistant clinical professor of dermatology at the Yale University School of Medicine, the associate director of clinical trials at CCD Research, and a 

 Editorial Advisory Board member, in an exclusive statement.

"There is a critical need for more dedicated research in women’s health care. As an advocate for women, I am inspired by Organon's commitment to elevating women’s health," said Latanya Benjamin, MD, a board-certified and fellowship-trained pediatric dermatologist, associate professor of pediatric dermatology at Florida Atlantic University, president of the Women's Dermatologic Society, and founder and owner of 

. "Their acquisition of Dermavant’s innovative product highlights their dedication to ensuring that women everywhere have access to top-tier dermatological solutions. I am hopeful that this will help set a new benchmark in global healthcare, prioritizing treatments that address women’s unique health needs and delivering more effective, specialized care.”

According to Organon’s announcement, psoriasis presents a significant impact to quality of life and atopic dermatitis is associated with a higher disease burden for women compared to men.”

"It is known that the diagnosis and therapy initiation for plaque psoriasis in women oftentimes overlaps with peak reproductive years with more than 75% of women being diagnosed before age 40. And despite lower PASI scores, psoriasis can have greater negative impacts on quality of life in women in comparison to men. It is also known that AD is more common in women than men with menstrual and pregnancy-related deteriorations of this disease. So, it is truly refreshing to see a health care company like Organon prioritize improving the health of women. We have certainly come a long way since the 90s," added Shahriari.

The efficacy and safety of tapinarof cream, an aryl hydrocarbon receptor agonist, for plaque psoriasis was evaluated in the phase 3 

 clinical trials. The efficacy and safety of tapinarof cream for atopic dermatitis was evaluated in the phase 3 

“We look forward to combining Dermavant’s strong dermatology commercial and field medical organization in the US, with Organon’s market access capabilities, regulatory expertise and worldwide commercial reach. This will allow us to bring Vtama cream, a patient-focused innovation in dermatology, providing an effective, well-tolerated, non-steroidal treatment option to the millions of people living with plaque psoriasis and potentially atopic dermatitis,” said Kevin Ali, chief executive officer of Organon, in the news release. “The acquisition will deliver on Organon’s objective of improving the health of women throughout their life stages by investing in treatments for conditions that affect women differently.”

“This is an unparalleled opportunity for continued growth and innovation for Dermavant, preserving our values and vision and allowing them to thrive in the new structure at Organon. We set out to revolutionize the standard of care in dermatology, and we delivered—becoming the #1 branded topical for plaque psoriasis within just two months after launching Vtama cream, and providing over 275,000 patients with the relief they desperately needed,” said Todd Zavodnick, chief executive officer of Dermavant, in the news release. “I am certain that this merger will provide us the scope and global scale to unleash the potential of Vtama cream.”

Organon will acquire Dermavant for aggregate consideration of up to approximately $1.2 billion, with an upfront payment of $175 million and a $75 million milestone payment once tapinarof cream is approved for atopic dermatitis, as well as payments of up to $950 million for the achievements of “certain commercial milestones.”

Organon to acquireDermavant including its innovative dermatologic therapy, VTAMA (tapinarof) cream, 1%. News release. Organon. September 18, 2024. Accessed September 18, 2024. 

https://www.organon.com/news/organon-to-acquire-dermavant-including-its-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/

FDA approves Dermavant’s Vtama (Tapinarof) cream, 1% for the treatment of plaque psoriasis in adults: first topical novel chemical entity launched for psoriasis in the US In 25 years. News release. Dermavant Sciences. May 24, 2022. Accessed September 18, 2024. 

https://dermavant.com/u-s-fda-approves-our-novel-topical-treatment-for-adults-with-plaque-psoriasis/

Dermavant announces FDA acceptance of supplemental new drug application (sNDA) for VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. News release. Dermavant Sciences. April 29, 2024. Accessed September 18, 2024. 

https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/

Dermavant’s sNDA for tapinarof cream 1% for AD is still under review with the FDA. 

News 

clinical

Organon to Acquire Dermavant Sciences and Tapinarof Cream 

Hyperhidrosis is not rare. According to the 

, approximately 385 million people worldwide live with hyperhidrosis.

In fact, they note that the amount of people living with chronic, excessive sweating is even higher than the amount of people living with other dermatologic conditions like psoriasis.

Just how common is hyperhidrosis in real-world comparisons?

The prevalence of hyperhidrosis is much higher in younger populations than in the general population, with 8.8% of individuals between the ages of 18 to 39 years old living with the condition. 

When comparing these statistics to everyday, common occurrences like hair color, the number of people with hyperhidrosis is greater than the 1% of individuals with natural red hair and 2% of individuals with natural blond hair. 

Despite how common hyperhidrosis is, it is estimated that 27% of those with the condition never receive a diagnosis.

 wants to hear from you. What percentage of the global population is estimated to have hyperhidrosis?

 to share your hyperhidrosis insights or research.

Albert. Fact check: Hyperhidrosis - International Hyperhidrosis Society: Official site. Home - International Hyperhidrosis Society. October 24, 1970. Accessed November 16, 2023. 

https://www.sweathelp.org/home/news-blog/542-fact-check-hyperhidrosis.html

Click here to answer this week's poll for Hyperhidrosis Awareness Month.

Polls 

POLL: What Percent of the Global Population is Estimated to Have Hyperhidrosis?

 approximately 2% of people worldwide will experience hair loss due to alopecia areata in their lifetime. 

When taking this statistic into account, approximately 160 million people globally have had, currently have, or will have alopecia areata, including approximately 6.7 million in the US. 

At this moment in time, it can be approximated that 700,000 people in the US, both children and adults, currently have some form of alopecia areata.

Alopecia areata - National Alopecia Areata Foundation. NAAF. June 23, 2023. Accessed August 11, 2023. 

This Hair Loss Awareness Month, test your knowledge of hair loss conditions. Click here to answer this week's poll.

POLL: What Percentage of People Worldwide Will Experience Alopecia in Their Lifetime?

The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's lebrikizumab-lbkz (Ebglyss)

 for children and adults aged 12 years and older with moderate to severe atopic dermatitis (AD).

The IL-13 inhibitor is intended for adults and pediatric patients whose AD has not yet been controlled through the use of topical therapies. Children 12 years of age and older must weigh at least 88 pounds (40 kg).

The approval is supported by positive data stemming from the ADvocate 1, ADvocate 2, and ADhere studies.

"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, in a news release.

 Silverberg is also the first author of the manuscript for the clinical trials related to lebrikizumab. 

The studies, involving over 1,000 patients with moderate to severe eczema who didn't respond to topical treatments, primarily measured clear or almost clear skin at the 16 week mark. 

In an average of the ADvocate 1 and ADvocate 2 studies, 38% of those using lebrikizumab achieved clear skin at 16 weeks, compared to 12% with placebo, and 10% saw results as early as 4 weeks. Of those who achieved clear skin, 77% maintained it for a year with monthly doses, and 48% maintained it even after switching to placebo.

For itch relief, 43% of lebrikizumab users experienced relief at 16 weeks, versus 12% with placebo, with 5% feeling relief as early as 2 weeks. Among those with itch relief at week 16, 85% continued to feel relief after a year on monthly maintenance, and 66% maintained relief after switching to placebo.

"Today's FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough," he said.

Kristin Belleson, president and CEO of the 

, weighed in on the approval's significance for patients.

"Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the US have eczema, with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration and rashes, which can lead to more scratching that may cause skin to crack and bleed," Belleson said. "The approval of Ebglyss provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."

Lebrikizumab was approved by the European Commission in 2023,

 Japan in January 2024, and Canada in June 2024.

Lebrikizumab will be available as a 250 mg/2 mL injection and may be used with or without topical corticosteroids. Lilly anticipates the drug will become available in the US in a matter of weeks. 

FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. News release. Lilly. September 13, 2024. Accessed September 13, 2024. 

https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with

Almirall. Almirall receives European Commission approval of Ebglyss (lebrikizumab) for moderate-to-severe atopic dermatitis. News release. November 17, 2023. Accessed September 13, 2024. 

https://www.almirall.com/newsroom/news/almirall-receives-european-commission-approval-of-ebglyss-lebrikizumab-for-moderate-to-severe-atopic-dermatitis

Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older. News release. Cision; Eli Lilly Canada Inc. June 25, 2024. Accessed September 13, 2024. 

https://www.newswire.ca/news-releases/health-canada-authorizes-lilly-s-ebglyss-tm-lebrikizumab-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-adults-and-adolescents-12-years-and-older-833722064.html

Ebglyss is now approved for children and adults aged 12 years and older.

FDA Approves Lebrikizumab-lbkz for Moderate to Severe Atopic Dermatitis

"Atopic dermatitis (AD) remains a challenging condition to manage effectively, and despite advances in treatment, there is a persistent issue of therapeutic inertia in the field. This inertia, characterized by the failure to escalate treatment when patients do not meet their therapeutic targets, continues to undermine patient outcomes. The 

 has highlighted this issue in the real-world, showing that many patients with moderate-to-severe AD remain undertreated, leading to inadequate disease control and reduced quality of life," wrote Christopher Bunick, MD, PhD, associate professor of dermatology and translational biomedicine at Yale University School of Medicine in New Haven, Connecticut, and 

recent review of new atopic dermatitis treatment targets.

The chronic physical symptoms of AD such as itchy and painful skin are often associated with affecting patients’ quality of sleep, sexual and social interactions, and work productivity. Due to the mental and physical effects of AD combined with dissatisfaction with current treatment regimens, more effective therapies are needed. 

Answer the poll below to learn more about recently published atopic dermatitis treatment recommendations.

The TARGET-DERM registry longitudinal study highlighted the continued trend of the failure to escalate atopic dermatitis treatments when patients do not meet their therapeutic targets.

POLL: When Do You Escalate AD Treatment if Treatment Targets are Not Achieved?

Each year, dermatology clinicians have a plethora of conferences to attend across the US, and even internationally. Although you may not be able to attend them all, there is no shortage of new data presented at each conference. Specific meetings geared towards dermatology advanced practice providers are growing in both quantity and size. Just last month, the inaugural Inflammatory Disease Summit in Las Vegas, Nevada, kicked off an exciting first year. 

Out of the meetings listed below, which one did you enjoy the most? Or, email us at 

As we get ready to plan for a busy 2024, check back for additional meeting opportunities!

Fall Clinical Dermatology Conference for PAs & NPs

Society of Dermatology Nurse Practitioners

Society of Dermatology Physician Assistants

Dermatology Education Foundation (DEF) - DERM2023 NP/PA CME Conference 

DEF Biologic & Small Molecule NP/PA CME Bootcamp

Masterclasses in Psoriatic Disease Plus for APP+

Click here to answer this week's NP & PA poll. Out of the meetings listed below, which one did you enjoy the most?

Duane Feger

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