Galderma Group AG

Galderma's Relfydess Shows Rapid, Long-Lasting Improvement for Frown Lines in Phase IIIb Trial

4 months ago

• Phase IIIb RELAX trial data demonstrates rapid onset of aesthetic improvement with Relfydess (RelabotulinumtoxinA) for frown lines, with 40% of subjects reporting improvement on Day 1. • The study showed long-lasting efficacy, with 69% of subjects satisfied at Month 6 and 60% at Month 12, highlighting sustained benefits of the treatment. • RelabotulinumtoxinA continues to be well-tolerated, with no treatment-related serious adverse events reported, reinforcing its safety profile. • Galderma's Relfydess has received approvals in 14 European countries, Australia, and the UK, expanding its availability for aesthetic use.

Galderma's Nemolizumab (Nemluvio) Receives FDA Approval for Moderate-to-Severe Atopic Dermatitis

5 months ago

• The FDA has approved Nemluvio (nemolizumab) for moderate-to-severe atopic dermatitis in patients 12 years and older when topical treatments are inadequate. • Nemolizumab is the first monoclonal antibody targeting IL-31 receptor alpha, offering a novel approach to reduce itch and inflammation associated with atopic dermatitis. • Clinical trials showed significant improvements in skin clearance, itch relief, and sleep disturbance with nemolizumab in combination with topical treatments. • Galderma anticipates peak sales of nemolizumab to exceed $2 billion, with potential blockbuster status by the end of 2027.

FDA Approves Galderma's Nemluvio as First IL-31 Inhibitor for Prurigo Nodularis

9 months ago

• The FDA has approved Galderma's Nemluvio (nemolizumab) as the first IL-31 receptor mAb for treating prurigo nodularis, a rare skin condition. • In Phase III trials, Nemluvio demonstrated a significant reduction in itch intensity compared to placebo, with results comparable to Dupixent. • Nemluvio offers a new treatment option for prurigo nodularis patients, addressing a condition with limited existing therapies. • The approval marks a significant milestone for Galderma and provides a competitive alternative to existing treatments like Dupixent.