— 80.7% (574/711) of patients achieved EASI75 (at least a 75% reduction in disease burden) in an integrated analysis of all the ADORING Program studies — — 77.9% (218/280) of patients ≥12 years old with a baseline PP-NRS (itch) score ≥4 achieved a ≥4-point reduction in PP-NRS. In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application — — 73% (519/711) of patients included in the integrated analysis achieved a vIGA-ADTM score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline — — 51.2% (373/728) of patients achieved complete disease clearance (vIGA-AD score of 0) in an interim analysis of the ADORING 3 open-label, long-term extension study— — No new safety signals were observed with up to 56 weeks of treatment — — Data from these analyses will be included in the sNDA submission for VTAMA cream, 1% expected in Q1 2024 — LONG BEACH, Calif., and BASEL, Switzerland, January 11, 2024 –
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-positive-data-from-the-adoring-phase-3-development-program-in-atopic-dermatitis-with-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as/
— 88.5% of adult patients achieved a target lesion Physician Global Assessment (tPGA) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at Week 12 (tPGA Success), reinforcing strong efficacy in these areas — — 80.8% of adult patients achieved tPGA score of 0 (clear) at Week 12, indicating complete clearance of the target plaque psoriasis lesion in the head and neck region — — 96.2% of patients achieved ≥ 75% improvement in Psoriasis Area and Severity Index (PASI75) of the head and neck region at Week 12 — — 70% of the adult patients achieved the widely followed standard of improvement in itch as measured by the Peak Pruritis-Numeric Rating Scale (PP-NRS) (head and neck region) of ≥ 4 points at Week 12, with some patients achieving this meaningful reduction in itch as early as Week 1 — — 96.7% of patients strongly agreed or agreed that VTAMA cream quickly absorbs and 93.3% of subjects strongly agreed or agreed that VTAMA cream was not greasy,
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-positive-results-from-phase-4-open-label-trial-of-vtama-tapinarof-cream-1-for-the-treatment-of-plaque-psoriasis-in-the-head-and-neck-region-in-a/
sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued group Filing acceptance reinforces Samsung Bioepis and Organon’s commitment to provide better access to biologic medicines for patients in the United States INCHEON, Korea & JERSEY CITY, N.J. –November 07, 2023 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental Biologics License Application (sBLA) for the interchangeability designation for HADLIMA™ (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira ® (adalimumab). The sBLA was submitted to the FDA by Samsung Bioepis in August 2023. The sBLA submission was based on clinical data from the Phase 4, randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose, active comparator, multicenter clinical
https://www.organon.com/news/samsung-bioepis-organon-announce-fda-acceptance-of-supplemental-biologics-license-application-sbla-for-interchangeability-designation-for-hadlima-adalimumab-bwwd-a-biosimilar-to-humira/
Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced the appointment of Juan Camilo Arjona Ferreira, M.D., as Chief Medical Officer (CMO) and Charlotte Owens, M.D., as Head of Medical Affairs and Outcomes Research, strengthening the company’s global clinical and medical capabilities, advancing external relationships and fueling efforts to bring forward innovations to solve unmet health needs. Both positions report directly to Sandra Milligan, M.D., J.D., Head of Research and Development. Dr. Arjona Ferreira brings over two decades of clinical research and development experience and a strong background in women’s health. Most recently, he was CMO of Myovant Sciences Inc., and has previously held leadership roles in women’s health and other therapeutic areas at Shionogi and Merck, known as MSD outside of the United States and Canada. Earlier in his career, Dr. Arjona Ferreira practiced as an OB-GYN in university hospitals and private practice.
https://www.organon.com/news/organon-bolsters-research-development-expertise-with-two-leadership-appointments/
INCHEON, Korea & JERSEY CITY, N.J. – August 1, 2023 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira ® (adalimumab). The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study ( NCT05510063 ) for SB5 was conducted across 33 sites in four countries (Bulgaria, Czechia, Lithuania, Poland) from August 2022 to May 2023 in patients with moderate to severe chronic plaque psoriasis. The primary objective of the study was to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between Humira (ADL) and high-concentration SB5 versus patients receiving ADL continuously. All 371 patients who were enrolled in the study had no prior treatment with ADL and were treated in this study with ADL during a lead-in period of 13 weeks. At Week 13,
https://www.organon.com/news/samsung-bioepis-organon-announce-topline-results-from-interchangeability-study-of-sb5-humira-biosimilar/
Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve access and affordability for patients and the US health care system Organon & Co. (NYSE: OGN) & Samsung Bioepis Co., Ltd. today announced that HADLIMA™ (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now available to patients in the United States. Consistent with Humira, HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL) to provide patients with seamless continuity of care. “As the largest loss-of-exclusivity event in pharmaceutical history, this is a singular moment for the US health care system to embrace biosimilars. Every stakeholder should be invested in the success of this market to realize the value biosimilars can create for patients, providers, and the US health care economy,” said
https://www.organon.com/news/organon-samsung-bioepis-announce-us-launch-of-humira-biosimilar-hadlima-adalimumab-bwwd-in-multiple-presentations-consistent-with-originator/
– 45.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-ADTM response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% on vehicle (P<0.0001) – – All secondary endpoints were met with statistical significance, including 55.8% of subjects treated with VTAMA who achieved the key secondary endpoint of EASI75 at Week 8 (P<0.0001) – – Meaningful impact on the exploratory endpoint of pruritus (itch) was demonstrated with 61.1% of subjects, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Week 8 (P<0.0001) – – 91% of subjects from ADORING 1 & 2 elected to enroll into the Phase 3 ADORING 3 open-label, long-term safety study* – – ADORING 1 met the primary and all key secondary endpoints, consistent with the positive topline results from the Phase 3 ADORING 2 trial reported in March – – sNDA for VTAMA in atopic dermatitis anticipated to be filed with the FDA in Q1
https://www.organon.com/news/dermavant-issued-release-dermavant-reports-positive-topline-results-from-adoring-1-the-second-atopic-dermatitis-phase-3-trial-of-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as/
– Study demonstrated minimal-to-no systemic exposure despite maximal use – – Subjects were as young as 2 years old with up to 90% body surface area (BSA) affected and a mean BSA of 43% – – Maximal usage study utilized same dose of VTAMA cream, 1% currently FDA-approved for adult plaque psoriasis – LONG BEACH, Calif., and BASEL, Switzerland, November 8, 2022 —Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from its maximal usage study of VTAMA ® (tapinarof) cream, 1% in children down to age 2 years old with extensive burden of atopic dermatitis. “We are delighted with the results from our maximal usage study of VTAMA cream, 1% in atopic dermatitis, which for the first time demonstrated highly favorable safety, pharmacokinetics, and clinical improvement in pediatric patients as young as two years of age,” said Philip M. Brown, MD, JD, Chief Medical Officer of
https://www.organon.com/news/dermavant-issued-release-dermavant-announces-highly-favorable-results-from-pediatric-maximal-usage-study-of-vtama-tapinarof-cream-1-in-atopic-dermatitis/
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA ® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018. 1,2 “With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, Samsung
https://www.organon.com/news/samsung-bioepis-and-organon-announce-fda-approval-of-citrate-free-high-concentration-humira-biosimilar-hadlima-adalimumab-bwwd/
Every year, an estimated 15 million babies are born preterm (before 37 completed weeks of gestation) i; agent is being studied in an area of significant unmet need Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange Organon (NYSE: OGN), a global women’s health company and ObsEva (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company dedicated to improving women’s reproductive health, today announced that the companies have entered into an agreement whereby Organon will license the global development, manufacturing and commercial rights to ebopiprant (OBE022). Ebopiprant is an investigational, orally active, selective prostaglandin F2α (PGF2α) receptor antagonist being evaluated as a potential treatment for preterm labor by reducing inflammation and uterine contractions. If approved, it has potential to be a first-in-class innovation for this common and serious condition with no approved therapies for acute treatment of preterm labor in the United States. “This
https://www.organon.com/news/organon-and-obseva-enter-global-license-agreement-to-develop-and-commercialize-ebopiprant-obe022-an-investigational-agent-being-evaluated-as-a-first-in-class-treatment-for-preterm-labor/