Roche says FDA grants priority review for Actemra
Zurich : The U.S. Food and Drug Administration (FDA) has granted priority review designation of Roche's rheumatoid arthritis medication Actemra for giant cell arteritis (GCA), the Swiss drugmaker said.
"We will continue to work closely with the FDA to bring this investigational medicine to people with GCA as quickly as possible," Sandra Horning, Roche's chief medical officer and head of global product development, said in a statement.
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.
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