FX.co ★ Johnson & Johnson Seeks Approval Of Darzalex Faspro In US, Darzalex In EU For Myeloma Treatment

Johnson & Johnson has announced the submission of regulatory applications for Darzalex Faspro to the U.S. Food and Drug Administration and Darzalex to the European Medicines Agency. These submissions are based on data from the ongoing Phase 3 AQUILA study, evaluating Darzalex Faspro as a monotherapy for adult patients with high-risk smoldering multiple myeloma, a precursor to active multiple myeloma. If approved, Darzalex Faspro would become the first treatment available for patients with high-risk smoldering multiple myeloma. Additionally, during pre-market trading hours, Johnson & Johnson's stock is slightly up, trading at $156.87, an increase of 0.09 percent on the New York Stock Exchange.