Botulinum toxin A (Q-Med)

The FDA has approved Galderma Pharma's Nemluvio to treat prurigo nodularis. The nod comes two years after the agency signed off on Regeneron and Sanofi's Dupixent as the first treatment for the skin disorder. Five months after scoring the world’s largest IPO in the first quarter, Swiss skincare specialist Galderma Pharma has earned FDA approval for Nemluvio (nemolizumab) to treat the debilitating and itchy skin disease prurigo nodularis (PN).Nemluvio, which comes in a prefilled pen for monthly subcutaneous injection, is a first-in-class monoclonal antibody that inhibits the signaling of IL-31, a neuroimmune cytokine which fuels the disease mechanisms of PN.Those with the chronic inflammatory skin disorder develop thick, pink-colored nodules on their arms and legs. It is estimated that 181,000 people in the U.S. have the underrecognized and underdiagnosed condition, which causes sleep disturbances. Topical steroids have been the standard of care for PN, bringing with them the potential for severe side effects when used over long stretches of time.Two years ago, Regeneron and Sanofi’s Dupixent became the first treatment approved by the FDA to specifically to treat PN. The monoclonal antibody blocks IL-4 and IL-13 proteins, which cause inflammation and swelling. Dupixent also is available in both a prefilled pen and prefilled syringe for injection under the skin every two weeks.Galderma’s approval is a “first step” in achieving Nemluvio’s “blockbuster platform potential and reinforces our leadership in therapeutic dermatology,” CEO Flemming Ornskov, M.D., said in a release. Galderma picked up nemolizumab in a licensing deal with Roche subsidiary Chugai Pharmaceutical in 2016. It was then a midstage asset under investigation for atopic dermatitis (AD) and pruritis (persistent itch) as it became the first biologic in Galderma’s topical-heavy portfolio.With the deal—which requires Galderma to pay royalties on sales of Nemluvio—the Swiss company gained the rights to develop and commercialize the treatment in all geographies except Japan and Taiwan. In Japan, nemolizumab has been approved for PN and is marketed as Mitchga. It also has been endorsed in Japan to treat AD patients of all ages who also have pruritis.The FDA granted nemolizumab breakthrough therapy designation in 2019 and priority review in February of this year. The agency also is reviewing nemolizumab for the treatment of AD, with a decision expected later this year. Regulators in several jurisdictions—including Europe, Canada and the U.K.—are also reviewing nemolizumab applications in both PN and AD.Approval of Nemluvio was backed by two phase 3 trials, which examined the effects of treatment over 16- and 24-week periods. At week 16 in the studies, 56% and 49% of Nemluvio-treated patients achieved at least a four-point reduction in itch intensity, as measured by a 10-point pruritis rating scale, compared to 16% in both placebo groups.At week 16, 26% and 38% of Nemluvio-treated patients reached a skin-clearance rating of zero or one—on a four-point scale—compared to 7% and 11% in the placebo group. Additionally, 50% and 52% of Nemluvio-treated patients achieved at least a four-point reduction in sleep disturbance at week 16, compared to 12% and 21% in the placebo groups.  In March, when Galderma was listed on the SIX Swiss Exchange, it drew an investment of nearly 2.3 billion Swiss francs ($2.6 billion). Galderma said that its public offering was its “next step” in becoming the world’s leading dermatology company.An IPO had been in the works since 2019, when European private equity firm EQT bought the company, formally known as Nestle Skin Health, for $10 billion. Galderma was formed in 1981 as a joint venture between cosmetics maker L’Oréal and food and beverage company Nestlé upon the invention of the first Cetaphil formulation.In October of last year, the FDA rejected Galderma's application for approval of RelabotulinumtoxinA, a liquid formulation of botulinum toxin to reduce wrinkles, citing manufacturing issues.