ZURICH Oct 5 Roche said the U.S. Food
and Drug Administration has granted it breakthrough status to
its anti-rheumatoid arthritis medication Actemra/RoActemra
(tocilizumab) for giant cell arteritis (GCA).
Giant cell arteritis is a chronic, potentially
life-threatening autoimmune condition caused by inflammation of
large and medium-sized arteries, most often in the head, but
also in the aorta and its branches.
"The FDA Breakthrough Therapy designation for GCA
underscores our continued commitment to explore
Actemra/RoActemra in autoimmune diseases with significant unmet
need," Roche Chief Medical Officer Sandra Horning said in the
"We are looking forward to working with the FDA in the hope
of making Actemra/RoActemra available to people with GCA, a
condition for which there has been no approved treatment in more
than 50 years."
(Reporting by John Revill; editing by Brenna Hughes Neghaiwi)