Actemra is intended to treat patients with giant cell arteritis, a chronic and potentially fatal autoimmune condition caused by inflammation of large and medium-sized arteries in the head or aorta.
The priority review process, which expedites the review of a drug application to about six months after filing, was created to decrease the time it takes to put new medicines on the market.
“We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible,” Sandra Horning, MD, CMO and head of global product development for Roche, said in a statement.
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