FDA Approves Subcutaneous Formulation of Actemra for Rare Form of Juvenile Arthritis

Rare Daily Staff

The U.S. Food and Drug Administration has granted approval to Genentech for a subcutaneous formulation of Actemra as a treatment for active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older.

SJIA is the rarest form of juvenile idiopathic arthritis (JIA), a chronic arthritic disease affecting children. JIA affects nearly 300,000 children in the United States, of which SJIA accounts for around 10 percent.  SJIA is characterized by inflammation in one or more joints, and a daily, spiking fever for at least two weeks, which may be accompanied by a skin rash. Other symptoms may include anemia, enlargement of the liver or spleen, and inflammation of the lining of the heart and/or lungs.

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 subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis and for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA), or SJIA. In addition, Actemra is also used as the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome.

“Systemic juvenile idiopathic arthritis is a rare, debilitating disease with limited treatment options,” said Sandra Horning, chief medical officer and head of global product development. “We are pleased to now offer physicians the flexibility to prescribe for children two years of age and older either Actemra IV, administered in a medical office, or Actemra subcutaneous, a prefilled syringe that can be injected at home.”

September 14, 2018
Photo: Sandra Horning, chief medical officer and head of global product development for Genentech