Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

Shots: 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…

ByDipanshu Dixit2 days ago

News

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Shots: 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…

ByRidhi RastogiJune 18, 2025

News

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots: 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…

ByRidhi RastogiMarch 10, 2025

News

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Shots: 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…

ByDipanshu DixitFebruary 18, 2025

News

Galderma’s Nemluvio (Nemolizumab) Secures the EU Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) and Prurigo nodularis (PN)

Shots: 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…

ByRidhi RastogiFebruary 14, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2024

Shots: 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…

ByDipanshu DixitJanuary 23, 2025

VIEWPOINTS

Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Shots: 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…

BySaurabh ChaubeyOctober 23, 2024

News

Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)

Shots: 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…

ByDipanshu DixitAugust 13, 2024

INSIGHTS+

Top Performing Drug – Dupixent (April Edition)

Shots: 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…

BySenior EditorApril 26, 2023

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Galderma’s Nemluvio (Nemolizumab) Secures the EU Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) and Prurigo nodularis (PN)

EMA Marketing Authorization of New Drugs in December 2024

Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)

Top Performing Drug – Dupixent (April Edition)

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