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ZURICH, Oct 5 (Reuters) - 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 release.
"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)