First FDA nod for juvenile arthritis drug in 5 years

May 2, 2013 | Thursday | Regulatory | By BioSpectrum Bureau

Singapore: Genentech, a member of the Roche Group received approval for its polyarticular juvenile idiopathic arthritis (PJIA) drug Actemra (tocilizumab) from the US FDA. The medicine can be used in children two years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX) in people with PJIA.

PJIA is a form of juvenile idiopathic arthritis, also known as juvenile rheumatoid arthritis, a chronic disease of childhood that affects approximately 100 in every 100,000 children. 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.

Dr Hal Barron, chief medical officer and head, global product development, Genentech, said that, "Polyarticular juvenile idiopathic arthritis is a rare, debilitating condition in children that worsens over time. We are pleased to offer Actemra to doctors and parents of children aged two or older as an important medicine to help improve the signs and symptoms of this often painful disease."

The FDA approval marks the second Actemra indication in children and is the first FDA approval for the treatment of PJIA in approximately five years.

Sign up for the editor pick and get articles like this delivered right to your inbox.

+Country Code-Phone Number(xxx-xxxxxxx)

Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account