Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots

Shots: 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…

BySaurabh ChaubeyJune 30, 2025

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) trialsInterim 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

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

NEWS

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)

Shots: The US FDA has approved Nemluvio + TCS ± calcineurin inhibitors (TCI) to treat mod. to sev. atopic dermatitis in patients unresponsive to topical therapies Approval was based on the P-III (ARCADIA) study of the combination vs PBO in patients (n=1,728; ≥12yrs.), showing significant skin clearance in both co-1EPs of IGA score (0/1) &…

ByDipanshu DixitDecember 13, 2024

NEWS

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis

Shots: The CHMP's recommendation of Nemluvio (SC) for mod. to sev. atopic dermatitis (≥12yrs.) & prurigo nodularis in eligible ones for systemic therapy was based on P-III ARCADIA & OLYMPIA studies, respectively. Reviews are ongoing in Australia, Singapore, Switzerland, Canada, Brazil & South Korea, with more filings underway ARCADIA 1 & 2 studies assessed…

ByDipanshu DixitDecember 13, 2024

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

Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots

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

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis

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)

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