FDA Approves Subcutaneous Actemra for Children with PJIA

Rare Daily Staff

The U.S. Food and Drug Administration approved the subcutaneous formulation of Genentech’s Actemra for the treatment in patients two years of age and older with active polyarticular juvenile idiopathic arthritis in patients, a rare and painful disorder.

PJIA is a form of juvenile idiopathic arthritis, a chronic disease of childhood. It affects approximately 100 in every 100,000 children, of which PJIA accounts for around 30 percent. PJIA is characterized by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.

Actemra was the first humanized interleukin-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief. Actemra can be given alone or in combination with methotrexate in patients with PJIA.

In 2013, FDA approved the intravenous formulation of Actemra for patients two years of age and older with active PJIA.

In general, the safety observed for Actemra administered subcutaneously was consistent with the known safety profile of Actemra IV, with the exception of injection site reactions and low white blood cell count.

May 15, 2018