J&J files with EMA and FDA for Darzalex in high-risk smouldering MM

US healthcare giant Johnson & Johnson (NYSE: JNJ) today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). This submission is based on promising data from the ongoing Phase III AQUILA study.

Licensed from Denmark’s Genmab (Nasdaq: GMAB), Darzalex is already a big seller for J&J, posting third-quarter 2024 sales of $3.02 billion, up 20.7%. Projections estimate that Darzalex will generate $11.5 billion in revenue this year, with forecasts predicting this figure will rise to $20 billion annually by 2030.

"There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high-risk of progressing to active multiple myeloma," said Dr Yusri Elsayed, global therapeutic area head, oncology, innovative medicine, Johnson & Johnson. "Darzalex has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm."