Galderma Secures FDA Approval for Nemluvio in U.S., Paving Path to Blockbuster Status

In August, the U.S. Food and Drug Administration (FDA) approved Galderma’s (SIX: GALD) Nemluvio (nemolizumab), marking a significant milestone for the Swiss skincare company. The treatment, delivered via a pre-filled pen for subcutaneous injection, is intended for adults suffering from prurigo nodularis (PN), a chronic skin condition. This approval makes Nemluvio the first monoclonal antibody (mAb) targeting IL-31 signaling to receive the green light in the U.S. The drug had previously secured FDA breakthrough therapy designation in December 2019 and priority review status in February 2024.

The approval is seen as a pivotal moment for Galderma, as it represents the company’s initial foray into biologic therapeutics. Analysts view this as a crucial de-risking event, setting the stage for further approvals in other indications and territories. Galderma is also awaiting FDA approval on Nemolizumab for atopic dermatitis (AD) later this year, with European approvals for both AD and PN expected in early 2025.

Consensus estimates from Visible Alpha suggest that Nemluvio will generate $15 million in revenue in 2024, surging to $121 million in 2025. By 2028, the drug is expected to achieve blockbuster status, with sales projected to reach $1.1 billion, and further growth anticipated to $2.1 billion by 2032. In 2024, Nemluvio is estimated to account for 0.3% of Galderma’s total revenue, with its contribution increasing to 21.9% by 2032.