Johnson & Johnson Seeks Approval Of Darzalex Faspro In US, Darzalex In EU For Myeloma Treatment

(RTTNews) - Johnson & Johnson (JNJ), Friday announced the submission of regulatory applications for Darzalex Faspro to the U.S. Food and Drug Administration, and Darzalex to the European Medicines Agency.

The applications rely on data from the ongoing Phase 3 AQUILA study of Darzalex Faspro as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma, an early precursor of active multiple myeloma.

If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma.

During the pre-market hours, Johnson & Johnson's stock is trading at $156.87, up 0.09 percent on the New York Stock Exchange.