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State: 17.08.2024 | 11PM
Fri, 08.11.2024       Johnson & Johnson
US4781601046

If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage

RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX®  subcutaneous (SC) formulation in the European Union (EU). The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220) of DARZALEX FASPRO® as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.1

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