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NPF Expands Seal of Recognition to FDA-approved Treatments and Awards its First to Arcutis' ZORYVE® (roflumilast)
NPF Expands Seal of Recognition to FDA-approved Treatments and Awards its First to Arcutis' ZORYVE® (roflumilast)

Associated Press

time4 days ago

  • Business
  • Associated Press

NPF Expands Seal of Recognition to FDA-approved Treatments and Awards its First to Arcutis' ZORYVE® (roflumilast)

ALEXANDRIA, VA, UNITED STATES, June 2, 2025 / / -- ● The NPF Seal of Recognition highlights products that prove a commitment to being safe and non-irritating for people with psoriasis or psoriatic arthritis. ● NPF has expanded its Seal of Recognition to include FDA approved prescription drugs to better represent the full toolbox of options available for people with psoriatic disease ● Recognition underscores ZORYVE's non-irritating use, even on hard-to-treat areas ● ZORYVE is the first and only FDA-approved branded topical in foam and cream options for plaque psoriasis treatment ● Psoriasis impacts more than 8 million people in the United States National Psoriasis Foundation (NPF), the leading advocacy, education, and research groups supporting people with psoriatic disease, and Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the awarding of the NPF's Seal of Recognition to Arcutis' ZORYVE® (roflumilast) cream 0.3% and ZORYVE® (roflumilast) topical foam 0.3%, both FDA approved for the treatment of plaque psoriasis. ZORYVE is the first FDA-approved product to receive the Seal of Recognition, which highlights products that have been created to be non-irritating and safe for people with psoriasis. 'The NPF Seal of Recognition is awarded to products that meet our rigorous standards for people living with psoriasis or psoriatic arthritis,' said Leah M. Howard, J.D., president and CEO of the NPF. 'We are pleased to expand our directory beyond over-the-counter items to recognize FDA-approved treatments like this one. It is great for our community to have multiple formulations that are suitable for sensitive and hard-to-treat areas. This reflects real progress in addressing the daily needs of people with psoriasis.' NPF's Seal of Recognition helps people with psoriasis and psoriatic arthritis find products that are safe and non-irritating for skin and joints. The program was launched in February 2012 and has grown over time, with NPF now adding new products regularly. The decision to expand the directory to include FDA approved products helps health care providers and people with the disease to see the full array of options for addressing psoriatic disease and its impactful symptoms. 'It is a tremendous honor that ZORYVE is the first FDA-approved product to receive the NPF Seal of Recognition. This is a testament to the dedication of our research, development, and technical operations teams to develop advanced targeted topical therapies,' said Frank Watanabe, president and CEO of Arcutis. 'Individuals living with psoriasis want steroid-free treatments that are safe and effective for long-term use, as well as convenient and versatile. With cream and foam formulations, ZORYVE offers individuals with psoriasis and their physicians a choice of their preferred formulation of ZORYVE, each providing powerful, long-term relief of plaques and itch anywhere on the body—including thin-skinned and hair-bearing areas—with no limitation on duration of use. This recognition reinforces our commitment to developing innovative therapies that meet the real-world needs of people with chronic inflammatory skin diseases.' For more information about the NPF Seal of Recognition, please visit For more information on ZORYVE, including prescribing information, please visit About Plaque Psoriasis Plaque psoriasis is the most common form of psoriasis, a chronic, systemic disease associated with inflammation throughout the body. Psoriasis affects more than 8 million people in the U.S. Symptoms include itch, scaling, redness, and flaking. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin area. In addition, scalp psoriasis sometimes extends to the forehead, back of the neck, or behind or inside the ears. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. About ZORYVE (roflumilast) ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses - including atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Roflumilast cream 0.15% (ZORYVE®) is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour's Beauty and Wellness Award for 'Eczema Product.' ZORYVE (roflumilast) topical foam, 0.3%, is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. INDICATIONS ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). Please see full Prescribing Information for ZORYVE cream and full Prescribing Information for ZORYVE foam. About the National Psoriasis Foundation The National Psoriasis Foundation is the leading nonprofit representing individuals with psoriasis and psoriatic arthritis. The mission of NPF is to drive efforts to cure psoriatic disease and improve the lives of more than 8 million individuals in the United States affected by this chronic immune-mediated disease. Learn more at About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis' unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential real-world use results of ZORYVE cream and ZORYVE foam in plaque psoriasis patients and the potential for ZORYVE to advance the standard of care in plaque psoriasis, atopic dermatitis and seborrheic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the 'Risk Factors' section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts: NPF Media Matt Werbach, NPF Director of Communications [email protected] Interested in Seal of Recognition? Nicole Kittelson, NPF Vice President of Corporate Relations Arcutis Media Amanda Sheldon, Arcutis Head of Corporate Communications [email protected] Investors Latha Vairavan, Arcutis Chief Financial Officer [email protected] Matthew Werbach National Psoriasis Foundation [email protected] Visit us on social media: LinkedIn Instagram Facebook X Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

A conductor gained 40 pounds in a matter of weeks. It took open-heart surgery to learn why
A conductor gained 40 pounds in a matter of weeks. It took open-heart surgery to learn why

CBS News

time24-05-2025

  • Health
  • CBS News

A conductor gained 40 pounds in a matter of weeks. It took open-heart surgery to learn why

Conductor John Mauceri is no stranger to health struggles. He was diagnosed with psoriatic arthritis in 2017, then chronic lymphocytic leukemia and interstitial lung disease in 2019. Medication treated the conditions and sent the cancer into remission, but he has remained on the lookout for recurrence. In December 2024, Mauceri, then 78, contracted COVID-19. He struggled to climb the stairs and developed a "troublesome" cough. He went to the emergency room at NYU Langone, where he has previously received medical care. An X-ray found viral pneumonia and severe lung disease. Doctors removed three liters of liquid from his right lung. The only relief, he said, was that there was no trace of cancer. He left the hospital about a week later. Within weeks, new symptoms quickly emerged. First, his left ankle swelled. Then the swelling continued up his leg. As the weeks passed, the swelling entered his abdomen and inched down his right leg. At one point, Mauceri was gaining a pound every day. He was also dealing with fatigue and shortness of breath. He couldn't conduct. "I was wearing somebody else's body, at least from my waist down. I couldn't wear normal clothes," Mauceri said. "Putting shoes on was hard. I couldn't walk through my house." John Mauceri at his 55th college reunion at Yale University in 2022. John Mauceri No one on his care team could identify what was causing the symptoms. "I had an oncologist, I had a pulmonologist, a rheumatologist. I had a lot of doctors, and they all thought it was somebody else's domain," Mauceri said. Searching for a diagnosis Dr. Adam Skolnick, a cardiologist at NYU Langone and one of Mauceri's doctors, said the team first looked for more common causes for the swelling. Mauceri underwent MRIs and other tests. An exam found his lymph system was working normally. Cardiac catheterization, where a thin tube is guided through the heart, found no signs of heart disease. There were no signs of blood clots, cancer recurrence or other likely conditions. Meanwhile, the swelling was beginning to strain Mauceri's body, putting him at risk of multi-organ failure. While studying the images of Mauceri's heart, Skolnick began to form a theory. But "the only definitive way to fully diagnose and treat Mr. Mauceri would be through surgery to open the chest," the doctor said. What is pericardial constriction? Skolnick thought Mauceri might have pericardial constriction, which occurs when the sac around the heart, or the pericardium, is thickened by scarring. That prevents the heart from fully opening. It can create pressure, resulting in swelling in the legs and abdomen. It's a rare condition that is usually acquired because of a prior illness, Skolnick said, including viral infections like COVID-19. Since there are no tests that look at the pericardium specifically, Mauceri would have to undergo open-heart surgery to confirm the diagnosis. The condition would also be treated in that same surgery. After Mauceri's care team eliminated all other possible options, they decided it was time to go into the operating room in June 2024. From left: Cardiology surgeon Dr. Eugene Grossi, cardiologist Dr. Adam Skolnick, John Mauceri, and rheumatologist Dr. Jonathan Samuels. Haley Ricciardi Mauceri was nervous about the prospect but it seemed like his only option. "There was no alternative," he said. "I said, 'Well, let's just do it.'" A high-risk surgery Dr. Eugene Grossi, a cardiothoracic surgeon and leader of NYU Langone Heart's robotic surgery team, performed Mauceri's surgery. When he opened the conductor's chest, he found that Mauceri's "heart was trapped" inside a thick shell of scarring. Typically, the pericardium is like a paper bag. Mauceri's was like shoe leather, Grossi said. "You don't think about it, but your lungs expand with every breath you take. Your chest wall opens. Your lungs expand. The heart does also, because it has to be able to accept the blood that's coming back from your arteries and veins. And his was just trapped," Grossi explained. That entrapment leads to fluid retention, creating swelling, Grossi said. Under the scarring, Mauceri's heart was functioning well. With the diagnosis made, Grossi and the surgical team had to scrape the pericardium and attached scar tissue carefully off the heart. Removing the pericardium creates no lasting health issues, but the procedure, called a pericardiectomy, is a delicate one. "It's almost like the heart is a hard-boiled egg, and we're peeling off the shell," Grossi said. Mauceri's procedure went smoothly, his doctor said. Once the pericardium was removed, Mauceri's urine output bag began to fill, proving to the surgeons that the pressure was off and blood was pumping smoothly. "Every day is a miracle" After Mauceri was released from the hospital, he quickly began losing weight. He said he feels like he's in the best shape he's been since college. "This is extraordinary because not only did I survive it, but I'm stronger than ever as a result of it," Mauceri said. John Mauceri at Paris' Notre Dame Cathedral after returning to conducting. John Mauceri His health struggles didn't end immediately. Shortly after the heart surgery, he was hospitalized again for a blockage of the small intestine. That was quickly treated, again at NYU Langone, but it slowed his recovery. It wasn't until December 2024, more than a year after he was diagnosed with COVID-19, that Mauceri was able to conduct an orchestra again. Mauceri conducted back-to-back performances in London and Paris, getting used to being onstage again. In May, he traveled to Japan to conduct in Tokyo. The 13-hour flight and long performance days felt like the first test of his endurance after his illnesses, he said. The performance was a raging success. John Mauceri conducts in Tokyo, Japan. Takayuki Shimizu Mauceri said he has no plans to slow down now that he's back to work. In between spending time with his family in New York City, he plans to travel the country for other concerts, including at the Hollywood Bowl in September, shortly after his 80th birthday. "I was conducting as if I wasn't on the cusp of being 80 anymore," he said. "I was allowed to do that because my doctors gave me this added time in my life where I can do that. So every day is a miracle. Every day I'm grateful for what they did."

Personal Milestone: Regaining My Full Strength After PsA
Personal Milestone: Regaining My Full Strength After PsA

WebMD

time22-05-2025

  • Health
  • WebMD

Personal Milestone: Regaining My Full Strength After PsA

This is a post I've wanted to write for a long time. Not because I needed to prove anything, but because I knew how much this moment would mean to me when it finally came. After four years of navigating life with psoriatic arthritis, I can finally say: I've regained my full strength. It still feels strange to put that into words. There was a time when that version of me felt completely out of reach – like she was part of a past life I'd never get back. But here I am. When I first got sick, I had no idea what was happening to me. The fatigue was relentless. Not the kind of tired you feel after a long day, but the kind that sinks in and doesn't go away no matter how much you rest. Everything became hard. Just getting out of bed took effort. Moving around the house felt like a workout. And over time, my muscles started to atrophy. I became so weak I could hardly recognize myself. I spent about six months in bed before I got on the right treatment plan. That half-year stripped me down in so many ways. Physically, I was barely functioning. Emotionally, I was overwhelmed. I grieved the version of myself who could do things without having to plan every movement. The one who could walk, lift, carry, stretch – without pain, without hesitation. During that time, I remember staring at my old workout clothes hanging in the closet, wondering if I'd ever be able to wear them again. Not just because they represented fitness, but because they symbolized a version of myself I missed deeply: capable, energized, free. I missed feeling strong not just in my body, but in my spirit. Back then, I wasn't sure I'd ever feel strong again. And honestly, there were many moments where I stopped trying to hope. It felt safer not to. Setting expectations too high only led to more disappointment, and I was already carrying enough grief. But slowly, piece by piece, I started rebuilding. Not in some cinematic, dramatic way. Just one day at a time. It started with sitting up more often. Then stretching. Then walking a little. Then lifting light weights – much lighter than what I was used to, but still a start. It was hard. It was humbling. It was slow. And sometimes it felt like nothing was happening. But over the years, with patience and consistency, I've worked my way back. There were so many moments when I had to celebrate the smallest wins: being able to unload the dishwasher without sitting down halfway through. Taking a shower and drying my hair without needing a nap afterward. Doing five bodyweight squats without my joints screaming at me. None of these things would be impressive to the average person – but to me, they were everything. Now, I'm lifting the same weights I could before all of this started. I'm doing the workouts I used to do, with modifications as needed. I'm moving with confidence again. That's not to say everything is easy now. I still need more rest. I still have to plan ahead. I still deal with symptoms. But I can do what I love again. And for me, that's huge. Strength has taken on a new meaning for me. It's no longer about what I look like or how many reps I can do. It's about what I've overcome. It's about continuing to show up for myself even when I'm tired or discouraged or flaring. It's about listening to my body and adjusting when I need to. It's about the resilience I've built by starting over again and again. What most people don't see is how much effort it takes behind the scenes. Planning workouts around medication timing. Making sure I recover properly. Accepting that some days I'll need to scale back. Giving myself grace when my body needs more than I want to give it. This isn't the same kind of strength I had before. But in many ways, it's more powerful now. Because it's hard-earned. Because I had to fight for it. And it wasn't just the physical effort; it was mental, emotional, and spiritual too. Rebuilding strength meant rebuilding trust with my body. After so many months of feeling like my body was betraying me, it took time to believe that we could be on the same team again. That my body wasn't the enemy – it was the place where healing could still happen, even if it didn't look like I expected it to. Looking back on those early days of diagnosis, it's hard to recognize myself. Not just because I was physically weaker, but because I felt so disconnected from the life I knew. I felt like I had lost so much of who I was. And it wasn't just about not being able to lift weights; it was about losing independence, confidence, even identity. Chronic illness can do that to you. It strips things away until you're forced to rebuild from the ground up. But that rebuilding process has changed me. It's made me slower, yes – but more intentional. Softer in some ways, but stronger in others. More aware of what actually matters. More grateful for the things I used to overlook. Now, every time I lift something heavy or go for a long walk or push through a workout, it feels like a small act of reclamation. Like I'm getting more of myself back. Not the exact same version I was before, but a version that's rooted, steady, and a lot more compassionate. There's also something incredibly grounding about knowing what it took to get here. When I see myself in the mirror or hit a new personal best at the gym, I don't just see muscle.I see perseverance. I see every bad day I moved through, every flare I didn't let define me, every painful step that led me back to movement. My strength isn't measured in pounds or performance anymore. It's measured in presence. In resilience. In grace. If you're in the thick of it right now – whether you're newly diagnosed, flaring, or just completely worn out – I hope this gives you a little hope. Not the kind that tells you everything will magically get better, but the kind that reminds you healing is possible in its own way, in its own time. Progress might be slow. It might feel invisible for a while. You might take two steps forward and one step back. But your body is still yours. Your strength is still there, even if it's buried under layers of pain and fatigue and frustration. You don't have to rush it. You don't have to force it. You just have to keep showing up when you can. And rest when you can't. You're not weak for needing more time. You're not failing because your recovery doesn't look like someone else's. Healing is not linear, and it definitely doesn't care about timelines. But it does happen. I'm proof of that. Four years ago, I couldn't walk across my house without getting winded. I couldn't lift 5 pounds. I couldn't imagine doing a full-body workout again. But now, I'm doing it. Not perfectly. Not always easily. But I'm doing it. And more than anything, I'm proud of that. Not proud in a 'look at me' way, but proud in a quiet, grounded way. The kind that comes from knowing what it took to get here. From remembering how hard it was. From honoring the version of me who didn't give up, even when she wanted to. So yeah, this is a milestone worth marking. Not because I'm 'back to normal,' but because I found my strength again. Because I now understand that strength can look different at different points in life, and that doesn't make it any less real.

Lefties With PsA May Have More Peripheral Damage
Lefties With PsA May Have More Peripheral Damage

Medscape

time20-05-2025

  • Health
  • Medscape

Lefties With PsA May Have More Peripheral Damage

Patients with psoriatic arthritis (PsA) who were left-handed had increased peripheral damage on radiographic assessment, particularly in the hands, with a greater impact observed on the left side. METHODOLOGY: The study used statistical models to prospectively evaluate data from 359 patients (57% men) with PsA who were followed for a median of 14 years. At baseline, the mean duration of cutaneous-only psoriasis was 15.8 years, the mean patient age was 43.7 years, and the mean body mass index was 28.3. A total of 35 patients were left-handed, which was defined as using the left hand to write. The primary outcome was the modified Steinbrocker score (mSS) based on radiographic assessment of the patients' hands (28 joints) and feet (12 joints), in which each joint was rated from 0 (normal) to 4 (total joint destruction, either lysis or ankylosis). TAKEAWAY: Left-handedness was significantly associated with increased overall radiographic progression in the hands, with a total estimated mSS in both hands of 6.34 (95% CI, 0.24-12.44; P = .04). = .04). Left-handedness was also significantly associated with radiographic progression in the left hand, with an estimated mSS in the left hand of 3.37 (95% CI, 0.25-6.48; P = .04). IN PRACTICE: 'It seemed that left-handed people — who have difficulty adjusting to everyday tools in a world where the majority of people are right-handed — had to adjust to assessment instruments, possibly reflecting real-world design bias,' the study author said in an interview. SOURCE: The study, led by Fadi Kharouf, MD, clinical research fellow at the University of Toronto/University Health Network, Toronto, was presented at the Spondyloarthritis Research and Treatment Network (SPARTAN) 2025 Annual Meeting. LIMITATIONS: The limitations of the study were not reported. DISCLOSURES: The study was conducted as part of the Gladman Krembil Psoriatic Arthritis Program, which is supported by the Krembil Foundation and the Schroeder Arthritis Institute. Kharouf disclosed that he is supported by a fellowship from the Kremlin Foundation.

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