Actemra/RoActemra revenue trends
Roche’s (RHHBY) Actemra/RoActemra reported revenues of 1.05 billion Swiss francs in the first half compared to 922.0 million Swiss francs in the first half of 2017, reflecting ~13% year-over-year (or YoY) growth at CER (constant exchange rates).
In the United States, Europe, and Japan markets, Actemra/RoActemra generated first-half revenues of 411.0 million Swiss francs, 347.0 million Swiss francs, and 164.0 million Swiss francs, respectively, reflecting ~16%, ~5%, and ~16% growth on a YoY basis at CER.
Actemra/RoActemra generated revenues of 550.0 million Swiss francs in the second quarter, reflecting ~13% YoY growth at CER.
In May, the FDA approved Actemra subcutaneous formulation for the treatment of individuals aged two years or above with active polyarticular juvenile idiopathic arthritis (or pJIA).
The FDA approved Actemra for monotherapy as well as in combination with methotrexate in individuals with pJIA. The FDA approved Actemra based on the results from the JIGSAW-117 trial.
In June, the Committee for Medicinal Products for Human Use (or CHMP) of the European Medicines Agency recommended a positive opinion for approval of RoActemra for the treatment of individuals aged above two years with cytokine release syndrome (or CRS). CRS is a life-threatening condition occurring as a side effect of CAR (chimeric antigen receptor) T-cell therapy utilized for the treatment of certain blood cancers.
The positive recommendation from CHMP comes after a retrospective analysis of data that was generated by Kite, now acquired by Gilead Sciences (GILD) and Novartis’ (NVS). Novartis and Kite, in their respective clinical trials with their CAR T-cell therapy, used RoActemra for treatment of CAR T-Cell therapy–induced CRS patients.
In August 2017, the FDA approved Actemra for the treatment of individuals with CAR T-cell therapy–induced CRS. The FDA has also granted Actemra an Orphan Drug Designation for treatment of CAR T-cell therapy–induced CRS.
The label expansion of Actemra/RoActemra is expected to boost the revenue growth of the drug in 2018 and beyond.