Galderma gets FDA nod for prurigo nodularis therapy
Galderma's chief executive Flemming Ørnskov
Dermatology specialist Galderma has FDA approval for prurigo nodularis treatment Nemluvio, one of two new drugs that it thinks will deliver blockbuster sales.
The US regulator cleared the IL-31 inhibitor as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis, a rare and highly debilitating skin disease that causes hard lumps to form on the skin that are so itchy they can lead patients to scratch themselves to the point of bleeding or pain. It affects around 181,000 people in the US.
The approval of Nemluvio (nemolizumab) is "a first step in achieving its blockbuster platform potential," according to Galderma's chief executive, Flemming Ørnskov.
The approval puts the new drug in contention in the US market with Sanofi and Regeneron's big-selling IL-4 and IL-13 inhibitor Dupixent (dupilumab), which became the first biologic to be approved for prurigo nodularis in 2022.
Previously, treatment typically involved oral or topical corticosteroids, antihistamines, and some antidepressant drugs, but responses to these are often inadequate, vary widely between patients, and come with the burden of safety risks if used long-term.
The approval is based on the results of the phase 3 OLYMPIA 1 and 2 clinical trials, which showed that Nemluvio achieved significant reductions in itch and skin nodules at week 16, with reductions in itch observed as soon as week four.
The FDA is also reviewing Nemluvio for the treatment of moderate-to-severe atopic dermatitis – another use in which the drug will cross swords with $12 billion-a-year Dupixent – with a decision expected later this year. Meanwhile, applications for both indications are under regulatory review in Europe as well as other countries, including Canada, Australia, Switzerland, and Singapore.
The FDA approval comes after Switzerland-based Galderma got its first approvals for its other blockbuster hopeful – botulinum toxin product Relfydess (relabotulinumtoxinA) – in Australia, as well as the EU under the decentralised procedure. Like main rival Botox from AbbVie's Allergan Aesthetics business, it is used to reduce facial wrinkles like glabellar lines.
If both new products reach their $1 billion-plus sales potential it could have a transformative effect on Galderma, which recorded total group revenues of $2.2 billion in the first half of this year. Ørnskov has previously said Nemluvio and Relfydess will start "contributing to the overall company performance as early as 2025."
Nemluvio's approval came in shortly after Galderma announced an R&D alliance with cosmetics giant L'Oreal, which has taken a 10% stake in the Swiss company. Galderma was originally formed as a joint venture between food giant Nestle and L'Oreal, before the latter exited the partnership in 2014.
