Corrects 5th graf to clarify Roche's Rituxan drug class
* U.S. FDA clears drug for use in rheumatoid arthritis
* Roche sees therapy as potential blockbuster
WASHINGTON, Jan 8 The U.S. Food and Drug
Administration has approved Roche Holding AG's ROG.VX Actemra
to treat rheumatoid arthritis, the company said on Friday.
The drug, made by Roche's Genentech unit, is already
approved for use in Europe and Japan and is expected by the
company to become a blockbuster product.
The FDA approved the drug for treatment of adults with
moderate to severe rheumatoid arthritis who do not respond well
enough to another class of biotech drugs designed to block an
inflammatory protein called tumor necrosis factor (TNF).
Actemra is an anti-interleukin-6 receptor antibody and
works differently from TNF blockers such as Humira, sold by
Abbott Laboratories (ABT.N), and Remicade, sold by Johnson &
Also known by its chemical name tocilizumab, Actemra will
compete against Roche's own B-cell inhibitor therapy Rituxan
and is seen by the company as a way to help diversify its
Actemra may be used alone or in combination with
methotrexate or other disease modifying anti-rheumatic drugs.
Patients with rheumatoid arthritis experience inflamed
membranes that line joints throughout the body, causing pain,
stiffness and disability. The condition is estimated to affect
more than 20 million people worldwide.
(Reporting by Susan Heavey and Deena Beasley; Editing