Janssen files sBLA for Darzalex Faspro in AL amyloidosis

US healthcare giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech today said it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies.

Darzalex Fasbro, which was approved by the FDA in May this year for for adult patients with newly-diagnosed or relapsed/refractory multiple myeloma, utilizes Halozyme’s ENHANZE technology.

The sBLA is supported by positive results from the Phase III ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate.