Johnson & Johnson (J&J) has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval for a new indication of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of high-risk smoldering multiple myeloma. This condition is a precursor to active multiple myeloma.
If approved, Darzalex Faspro would become the first therapy sanctioned for use in this patient population before the onset of full-blown disease. The applications are based on data from the Phase 3 AQUILA study, which evaluated Darzalex Faspro as a monotherapy in adults with high-risk smoldering multiple myeloma. This condition is characterized by the presence of abnormal cells in the bone marrow without the symptoms typical of active multiple myeloma. Currently, standard care involves observation until the disease progresses, but recent evidence suggests that early intervention could benefit patients at high risk of developing active multiple myeloma.
AQUILA Study and Potential Impact
The AQUILA study's initial results are scheduled to be presented at the American Society of Hematology (ASH) Annual Meeting in December. According to Dr. Yusri Elsayed of Johnson & Johnson, Darzalex has already altered the standard of care in multiple myeloma, and the company hopes that with FDA and EMA approval, it could transform the treatment landscape for patients with high-risk smoldering multiple myeloma.
Darzalex Faspro is currently approved for multiple indications in the treatment of multiple myeloma, both as a monotherapy and in combination with other drugs. It is the only subcutaneous CD38-directed antibody treatment approved for multiple myeloma patients. Janssen Biotech, Inc. and Genmab A/S have a partnership that grants Janssen the exclusive license to develop, manufacture, and commercialize daratumumab.
Darzalex Faspro: A CD38-Directed Antibody
Darzalex Faspro is a subcutaneous formulation of daratumumab, a CD38-directed antibody. CD38 is a transmembrane glycoprotein highly expressed on multiple myeloma cells. Daratumumab binds to CD38, inhibiting its function and triggering multiple myeloma cell death through various mechanisms, including antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct apoptosis.
Financial Performance and Analyst Outlook
Johnson & Johnson recently reported a strong third quarter with operational sales growth of 6.3%, totaling $22.5 billion. The company also raised its full-year guidance for the third consecutive quarter. Notably, the Innovative Medicine segment showed strength with sales exceeding $14 billion for two consecutive quarters. RBC Capital Markets and Stifel Financial adjusted their price targets for Johnson & Johnson following these robust results. RBC Capital Markets increased its price target from $178.00 to $181.00, while Stifel raised its target to $170 from the previous $160.
