Dive Brief:

• Galderma on Tuesday said the Food and Drug Administration has approved its antibody drug Nemluvio for adults with prurigo nodularis, a chronic skin condition characterized by intense itch.
• A subcutaneous injection, Nemluvio works by blocking cellular signaling via a cytokine called IL-31. Results from two Phase 3 clinical trials showed treatment helped to reduce itch intensity, clear skin and improve sleep, compared to a placebo.
• In an email, Galderma declined to disclose the price it plans to charge for Nemluvio. The company said the drug will be available in the coming weeks. 

Dive Insight:

Nemluvio’s clearance Tuesday comes only about two years after the first FDA approval of a prurigo nodularis treatment, for Sanofi and Regeneron Pharmaceuticals’ blockbuster medicine Dupixent.

While the two drugs work differently, they’re both designed to target the inflammatory roots of the condition, which besides itching leads to the hardening of the skin into thick nodules. It’s an underdiagnosed disease and, according to Galderma, affects as many as roughly 180,000 people in the U.S.

Galderma licensed Nemluvio, which is known scientifically as nemolizumab, from Chugai Pharmaceutical in 2016. The company advanced the drug into late-stage testing that involved more than 500 adults with prurigo nodularis, measuring whether treatment reduced itch intensity by at least four points on a rating scale after four months. Across two Phase 3 studies, 56% and 49% of treated participants hit that mark, compared to 16% in the respective placebo groups.

“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,” said Galderma CEO Flemming Ørnskov, who previously led Shire before its acquisition by Takeda Pharmaceuticals.

The company has also asked the FDA to approve Nemluvio in moderate-to-severe atopic dermatitis, and expects a decision later this year.

Editor’s note: This story has been updated with comment from Galderma.