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Emirates Drug Establishment Approves Tapinarof Cream 1%, A New Treatment For Plaque Psoriasis In Adults And Atopic Dermatitis In Adults And Children 2 Years Of Age And Older
(MENAFN- Mid-East Info)
“The approval of this product gives patients and caregivers a new, highly effective, steroid free, treatment that offers powerful skin clearance, and has the potential to transform how skin diseases are treated in the UAE,” said Ramy Koussa, Associate Vice President for Middle East, Turkey and Africa at Organon.“People living with psoriasis and AD may experience anxiety, depression and decreased self-esteem, all of which can have detrimental effects on personal relationships, career choices and social interactions.6, This burden fuels our mission to expand access to impactful medicines, so that more patients can live a healthier every day.” Psoriasis is characterized by red patches, scales, and lesions on the skin that cause itching and pain,, and is associated with disability levels on par with major health conditions such as cancer, hypertension, arthritis, diabetes, and heart disease.6 People with AD suffer from itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck,, and the disease has a higher prevalence among women. “Both AD and psoriasis are diseases that place a significant burden on patients' day-to-day life,” said Dr. Ayman Al Naeem, President of the Emirates Dermatology Society.“For young children, AD can interfere with sleep, mood, and developmental milestones that can burden the whole family. Having a non-biologic, steroid free treatment that is suitable for both children and adults, provides a new option for treating these diseases where other therapies may not be suitable. This allows for a more personalized treatment approach which is key to successful patient outcomes.” Tapinarof cream, 1% is applied once daily to affected areas, offering a simplified dosing regimen. Its mechanism of action restores the skin barrier, improves bothersome symptoms such as itching and offers the potential for complete skin clearance and treatment-free days. It has shown good results in patients of color and can be used on all skin surfaces, including the head, neck, and intertriginous areas where steroids are contraindicated, without limitations on use. Tapinarof cream, 1% became part of the Organon portfolio in the fourth quarter of 2024 as part of the company's acquisition of Dermavant. The UAE is among one of the first countries globally to make this treatment available outside of the US. About the PSOARING clinical studies: Tapinarof demonstrated significant improvement in the primary and secondary efficacy endpoints compared to vehicle cream in the PSOARING 1 and PSOARING 2 pivotal studies. The primary efficacy endpoint in PSOARING 1 (DMVT-505-3001) and PSOARING 2 (DMVT-505-3002) in adults with plaque psoriasis was the proportion of patients who achieved treatment success, defined as a Physician Global Assessment (PGA) score of“Clear” (0) or“Almost Clear” (1) and at least a 2-grade improvement from baseline to Week 12. PGA treatment success was observed in 35% and 40% of patients using tapinarof in trials 1 and 2 vs 6% for patients using vehicle cream in both trials (p<0.001). Secondary efficacy endpoints included PASI-75 (improvement of at least 75% in PASI score from baseline), change from baseline in %BSA, and PASI-90 (improvement of at least 90% in PASI score from baseline) at Week 12. The adverse event (AE) profile of tapinarof cream reported in both PSOARING 1 and PSOARING 2 demonstrated that the majority of AEs were localized to the site of application and were mild to moderate in nature. The most common AEs of subjects treated with tapinarof cream were folliculitis, nasopharyngitis, and contact dermatitis. Following 12 weeks of treatment in PSOARING 1 or PSOARING 2, eligible patients could receive an additional 40 weeks of treatment in an open-label extension trial (PSOARING 3) to evaluate tapinarof cream for long-term safety and maintenance of response. Patients entering with a PGA = 0 had treatment discontinued and were followed for durability of treatment (remittive response). In this long-term extension study, of the 74 patients who entered with clear skin (PGA=0), the median time off therapy before experiencing PGA ≥2 was 115 days (n=57); 95% CI: 85, 162. About the ADORING clinical studies: In the ADORING pivotal studies, tapinarof cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) 45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P<0.0001). The difference between patients who received tapinarof cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age. The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%). ADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were tapinarof cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria. In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with tapinarof cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with tapinarof cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with tapinarof cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8. About Organon: Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare.
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Tapinarof Cream 1% is the first and only steroid-free topical medication in its class, to be available in the UAE to treat atopic dermatitis (AD) and psoriasis.
Atopic dermatitis is a common inflammatory skin disease, commonly referred to as eczema, that affects around 16.7% of children in the UAE.
Approximately 2-3% of people worldwide live with psoriasis.
“The approval of this product gives patients and caregivers a new, highly effective, steroid free, treatment that offers powerful skin clearance, and has the potential to transform how skin diseases are treated in the UAE,” said Ramy Koussa, Associate Vice President for Middle East, Turkey and Africa at Organon.“People living with psoriasis and AD may experience anxiety, depression and decreased self-esteem, all of which can have detrimental effects on personal relationships, career choices and social interactions.6, This burden fuels our mission to expand access to impactful medicines, so that more patients can live a healthier every day.” Psoriasis is characterized by red patches, scales, and lesions on the skin that cause itching and pain,, and is associated with disability levels on par with major health conditions such as cancer, hypertension, arthritis, diabetes, and heart disease.6 People with AD suffer from itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck,, and the disease has a higher prevalence among women. “Both AD and psoriasis are diseases that place a significant burden on patients' day-to-day life,” said Dr. Ayman Al Naeem, President of the Emirates Dermatology Society.“For young children, AD can interfere with sleep, mood, and developmental milestones that can burden the whole family. Having a non-biologic, steroid free treatment that is suitable for both children and adults, provides a new option for treating these diseases where other therapies may not be suitable. This allows for a more personalized treatment approach which is key to successful patient outcomes.” Tapinarof cream, 1% is applied once daily to affected areas, offering a simplified dosing regimen. Its mechanism of action restores the skin barrier, improves bothersome symptoms such as itching and offers the potential for complete skin clearance and treatment-free days. It has shown good results in patients of color and can be used on all skin surfaces, including the head, neck, and intertriginous areas where steroids are contraindicated, without limitations on use. Tapinarof cream, 1% became part of the Organon portfolio in the fourth quarter of 2024 as part of the company's acquisition of Dermavant. The UAE is among one of the first countries globally to make this treatment available outside of the US. About the PSOARING clinical studies: Tapinarof demonstrated significant improvement in the primary and secondary efficacy endpoints compared to vehicle cream in the PSOARING 1 and PSOARING 2 pivotal studies. The primary efficacy endpoint in PSOARING 1 (DMVT-505-3001) and PSOARING 2 (DMVT-505-3002) in adults with plaque psoriasis was the proportion of patients who achieved treatment success, defined as a Physician Global Assessment (PGA) score of“Clear” (0) or“Almost Clear” (1) and at least a 2-grade improvement from baseline to Week 12. PGA treatment success was observed in 35% and 40% of patients using tapinarof in trials 1 and 2 vs 6% for patients using vehicle cream in both trials (p<0.001). Secondary efficacy endpoints included PASI-75 (improvement of at least 75% in PASI score from baseline), change from baseline in %BSA, and PASI-90 (improvement of at least 90% in PASI score from baseline) at Week 12. The adverse event (AE) profile of tapinarof cream reported in both PSOARING 1 and PSOARING 2 demonstrated that the majority of AEs were localized to the site of application and were mild to moderate in nature. The most common AEs of subjects treated with tapinarof cream were folliculitis, nasopharyngitis, and contact dermatitis. Following 12 weeks of treatment in PSOARING 1 or PSOARING 2, eligible patients could receive an additional 40 weeks of treatment in an open-label extension trial (PSOARING 3) to evaluate tapinarof cream for long-term safety and maintenance of response. Patients entering with a PGA = 0 had treatment discontinued and were followed for durability of treatment (remittive response). In this long-term extension study, of the 74 patients who entered with clear skin (PGA=0), the median time off therapy before experiencing PGA ≥2 was 115 days (n=57); 95% CI: 85, 162. About the ADORING clinical studies: In the ADORING pivotal studies, tapinarof cream, 1% demonstrated, in moderate to severe patients as young as 2 years old with AD, a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at Week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) 45.4% versus 13.9% of patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2 (both P<0.0001). The difference between patients who received tapinarof cream and those that received vehicle in all secondary endpoints was statistically significant, including the Eczema Area and Severity Index (EASI) score improvement of at least 75% (EASI75) from baseline at Week 8 and achievement of a ≥4-point improvement in the patients reported Peak Pruritus Numerical Rating Scale (PP-NRS) from baseline at Week 8 in patients ≥12 years of age. The most common adverse reactions (incidence ≥1%) were upper respiratory tract infection (12%), red raised bumps around the hair pores (folliculitis) (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and stomach-area (abdominal) pain (1%). ADORING 3, a 48-week open-label, LTE study, enrolled eligible patients from ADORING 1, ADORING 2, a 4-week maximal usage pharmacokinetics trial, and direct enrollees who were tapinarof cream-naive patients 2-17 years of age with mild, moderate or severe AD (vIGA-AD scores of 2, 3, or 4, respectively), that did not meet pivotal studies inclusion criteria. In ADORING 3, patients (N=728) were followed for up to 48 weeks, with safety and efficacy endpoints that included the achievement of complete disease clearance (vIGA-AD=0), and the achievement of clear or almost clear skin (vIGA-AD=0 or 1). Patients entering with any disease activity (vIGA-AD≥1) were treated with tapinarof cream, 1% until complete disease clearance was achieved (vIGA-AD=0) or study completion. For the 378 patients who entered with or achieved complete disease clearance (vIGA-AD=0) in ADORING 3 and discontinued treatment with tapinarof cream, the mean duration of the first treatment-free (remittive) interval was approximately 80 consecutive days. Patients whose AD returned to mild or above (vIGA-AD≥2) were re-treated with tapinarof cream until complete disease clearance was achieved again or study completion. The safety profile with long term use was generally consistent with the safety profile observed at Week 8. About Organon: Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare.
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