J&J Says DARZALEX SC Granted EU Approval For First Self-Administered Oncology Treatment

Johnson & Johnson announced that the EMA CHMP approved a Type II labelling variation for DARZALEX (daratumumab) subcutaneous formulation. The label update for DARZALEX SC represents a positive regulatory development in the EU that is supportive for the product's commercial positioning, though it is likely to have only a modest near-term impact on J&J's overall revenues.

Analysis

Johnson & Johnson announced that the EMA CHMP approved a Type II labelling variation for DARZALEX (daratumumab) subcutaneous formulation. The label update for DARZALEX SC represents a positive regulatory development in the EU that is supportive for the product's commercial positioning, though it is likely to have only a modest near-term impact on J&J's overall revenues.