Roche‘s (OTC:RHHBY) Genentech said today that the FDA approved its ACTPen single-dose prefilled autoinjector for Actemra as a new formulation for adults with moderate to severe active rheumatoid arthritis and for adults with giant cell arteritis.
The U.S. regulatory agency also approved the device for administration by caregivers to patients as young as two years old with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis.
The drug-device therapy is expected to hit the shelves in January next year.
Clinical trials have shown that the subcutaneous administration of a single dose of Actemra with the ACTPen is bioequivalent to administration with the currently marketed prefilled syringe, according to Genentech. Studies have also shown that the intended users of the device could successfully perform the tasks required to administer Actemra.
“When it comes to the administration of medicines, we believe patients should have choices, when possible,” Dr. Sandra Horning, CMO & head of global product development at Genentech, said in prepared remarks. “With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations.”