Galderma adds new indication for blockbuster hope Nemluvio

Dermatology specialist Galderma has claimed a second FDA approval for IL-31 inhibitor Nemluvio, adding atopic dermatitis to its label.

Nemluvio (nemolizumab) – which was approved by the FDA in the summer for the rare skin disorder prurigo nodularis – can now be used in the US to treat patients aged 12 years and older with moderate-to-severe atopic dermatitis, also known as eczema, that is not controlled using topical prescription therapies alone. The drug has also just been recommended for both indications in the EU.

Getting approval in atopic dermatitis is viewed as a key step in Galderma's pursuit of $1 billion-plus sales for Nemluvio as the patient population for the new indication is much larger.

It is estimated that around 7% of the US population has some degree of atopic dermatitis – around 16.5 million people – and around a third of them will have moderate to severe symptoms.

The market for atopic dermatitis therapies is getting pretty crowded, however, and first-in-class Nemluvio will have to take on established therapies like Sanofi and Regeneron's market-leading IL-4 and IL-13 antagonist Dupixent (dupilumab), which is also cleared for prurigo nodularis.

There are several other newer entrants as well, like Almirall's Ebglyss (lebrikizumab) and Leo Pharma's Adtralza (tralokinumab), both IL-13 inhibitors, and a clutch of oral JAK inhibitors including Eli Lilly's Olumiant (baricitinib), AbbVie's Rinvoq (upadacitinib), and Pfizer's Cibinqo (abrocitinib).

Galderma thinks that Nemluvio's mechanism of action could make it particularly effective against itch, one of the most debilitating symptoms of atopic dermatitis, and help to differentiate it from its rivals.

The FDA approval of the drug is based on the results of the ARCADIA trial, which compared Nemluvio to placebo given on top of standard atopic dermatitis therapies, including topical corticosteroids (TCS) or calcineurin inhibitors (TCI), in more than 1,700 patients.

The results showed that patients treated with Nemluvio, administered subcutaneously every four weeks in combination with TCS, with or without TCI, showed statistically significant improvements in skin clearance and also helped to relieve itch in some patients as early as a week after initial dosing.

"Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain," according to Galderma's chief executive, Flemming Ørnskov.

He added that the FDA approval "will accelerate the ongoing growth of our US organisation and our therapeutic dermatology business."

Earlier this year, Switzerland-based Galderma got its first approval for another blockbuster hopeful – botulinum toxin product Relfydess (relabotulinumtoxinA) – that is a rival to AbbVie/Allergan's wrinkle treatment Botox.

If both new products reach their $1 billion-plus sales potential it would have a transformative effect on Galderma, which recorded total group revenues of $3.26 billion in the first nine months of this year.