BRIEF—Darzalex submission in rare disease

Johnson & Johnson’s pharma arm, Janssen, has submitted to the European regulator to broaden the label for Darzalex (daratumumab) subcutaneous (SC) formulation, to include the treatment of people with light chain (AL) amyloidosis.

AL amyloidosis is a rare and potentially fatal disease that occurs when amyloid builds up in tissues and organs, interfering with healthy function. There are currently no therapeutic options approved for the treatment of the disease.

The submission is supported by data from the Phase III ANDROMEDA study, which were presented at the 2020 European Hematology Association (EHA) Annual Congress.