The FDA has granted Breakthrough Therapy designation for enpatoran, an oral drug from Merck KGaA to treat active skin manifestations in patients with lupus.
Enpatoran is a selective toll-like receptor (TLR) 7/8 inhibitor that modulates pathways that are key to inflammation in patients with lupus. It demonstrated a meaningful improvement in symptoms in the phase 2 WILLOW trial, which tested the drug on patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE).
There are currently no approved therapies for cutaneous manifestations of lupus. The Breakthrough Therapy designation will expedite the drug development and review process, with the aim of bringing lupus patients a treatment option that provides a substantial improvement to their symptoms sooner. Two phase 3 trials — ELOWEN 1 and ELOWEN 2 — are already in place to further investigate a link between skin and systemic disease activity.