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Backed by positive results from the P-III ARCADIA study, Galderma’s Nemluvio recently received approval from the US FDA for patients with moderate to severe atopic dermatitis
Nemluvio (nemolizumab) has previously been approved for the treatment of prurigo nodularis
Christophe Piketty, VP, Head of Innovation, Therapeutic Dermatology, Global Clinical Sciences, Galderma, highlighted insights from the…
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Galderma announced the initiation of two P‑II clinical studies evaluating the efficacy and safety of nemolizumab in pts with SSc and CPUO
Patient enrollment for both studies is planned to start in H2’25, with expected completion in 2028 for SSc and in 2026 (US) for CPUO
Nemolizumab is a mAb targeting the IL‑31 receptor…
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The OLYMPIA long-term extension study assessed Nemluvio in 508 pts with prurigo nodularis up to 4yrs., which were enrolled from the P-II or P-III (OLYMPIA 1 & 2) trials
Interim analysis at Wk. 100 showed sustained improvement, with over 90% achieving ≥4-point itch reduction & 70% being itch-free or nearly itch-free per Peak-Pruritus Numerical…
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Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks
TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…
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The UK’s MHRA & Swissmedic have approved Nemluvio (SC) for mod. to sev. PN & AD, where it is approved in adults for PN & in combination with TCS ± TCI in pts (≥12yrs.; ≥30kg) for AD who are candidates for systemic therapy. Awaits approval in Singapore & Australia
Approval is based on P-III…
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Based on ARCADIA and OLYMPIA studies EU approved Nemluvio for moderate-to-severe AD and PN and is now approved for SC use in pts. aged 12 and older for AD and in adults for PN who are candidates for systemic therapy
ARCADIA 1 & 2 studies assessed Nemluvio (Q4W) + TCS ± TCI vs PBO…
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The EMA’s CHMP has granted positive opinions to 5 Biologics and 4 New Chemical Entities in December 2024, leading to treatments for patients and advances in the healthcare industry
The major highlighted drugs were Galderma’s Nemluvio to treat Prurigo Nodularis and Atopic Dermatitis
PharmaShots has compiled a list of 9 drugs that have been granted positive…
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Galderma’s Nemluvio (nemolizumab) was recently approved by the US FDA for the treatment of adults with prurigo nodularis, following positive Phase III results from the OLYMPIA study.
Today at PharmaShots, we have Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, to discuss the study’s design and the potential of Nemluvio in…
Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)
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The approval of Nemluvio (SC pre-filled pen) was based on P-III (OLYMPIA 1 & 2) studies assessing its safety & efficacy vs PBO in PN patients (n= >500)
Studies met their 1 & 2EPs, showing at least a 4-point reduced itch intensity in 56% & 49% vs 16% (both PBO groups); skin nodules clearance…
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In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have selected Dupixent and prepared a curated analysis report for our readers
Dupixent is an interleukin-4 receptor alpha antagonist used for the treatment of multiple indications including atopic dermatitis, asthma, eosinophilic esophagitis, etc.
PharmaShots…

