Galderma secures FDA nod for skin condition therapy

Galderma announced on Tuesday that the Food and Drug Administration (FDA) has given its approval for Nemluvio, an antibody drug designed for adults suffering from prurigo nodularis. This chronic skin condition is known for causing intense itching. Nemluvio, which is administered through a subcutaneous injection, operates by inhibiting cellular signaling via a cytokine called IL-31. Data from two Phase 3 clinical trials demonstrated that the treatment effectively reduced itch intensity, cleared the skin, and improved sleep quality when compared to a placebo.

Galderma has not yet disclosed the pricing details for Nemluvio but indicated that the drug would be available in the coming weeks.

Nemluvio’s approval marks a significant milestone, coming just about two years after the initial FDA approval of a prurigo nodularis treatment. The first treatment, Sanofi and Regeneron Pharmaceuticals' Dupixent, has become a blockbuster. While Nemluvio and Dupixent operate through different mechanisms, both aim to address the inflammatory roots of prurigo nodularis. Besides intense itching, this condition also causes the skin to harden into thick nodules. According to Galderma, prurigo nodularis is often underdiagnosed and affects an estimated 180,000 people in the United States.

Galderma obtained the rights to Nemluvio, scientifically known as nemolizumab, from Chugai Pharmaceutical in 2016. The company then proceeded to advance the drug into late-stage clinical trials involving over 500 adults with prurigo nodularis. The trials specifically measured whether the treatment could reduce itch intensity by at least four points on a rating scale after four months. Results from the two Phase 3 studies showed that 56% and 49% of participants receiving Nemluvio achieved this reduction, compared to just 16% in the respective placebo groups.

Flemming Ørnskov, CEO of Galderma and former leader of Shire before its acquisition by Takeda Pharmaceuticals, emphasized the significance of the FDA's rapid approval. "The U.S. FDA's rapid approval of Nemluvio in prurigo nodularis is a first step in achieving its blockbuster platform potential and reinforces our leadership in therapeutic dermatology," Ørnskov stated.

In addition to its approval for prurigo nodularis, Galderma is seeking FDA approval for Nemluvio in the treatment of moderate-to-severe atopic dermatitis and anticipates a decision later this year.