FDA accepts filing of sBLA for Actemra (tocilizumab) for the treatment of Giant Cell Arteritis and grants priority review.- Genetench/Roche
Genentech, announced that the FDA has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra (tocilizumab) for the treatment of Giant Cell Arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The FDA also granted Priority Review Designation for Actemra for the treatment of GCA.
The designation is based on the positive outcome of the Phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid taper regimen given alone in people with GCA.
“Treatment to date for GCA has been limited to high-dose steroids to rapidly control inflammation and prevent serious complications,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “However, steroid treatment often fails to control disease in the long-term and can be associated with severe side effects. If approved, Actemra could have the potential to fundamentally change the way people with GCA are treated".
Comment: GSK/Janssen have in Phase III development CNTO 136 (sirukumab) to treat the condition.
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