The US Food and Drug Administration (FDA) has accepted Genentech’s supplemental biologics licence application (sBLA) for Actemra (tocilizumab) for the treatment of Giant Cell Arteritis (GCA).
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GCA is a chronic, potentially life-threatening autoimmune condition that can lead to blindness if left untreated.
Genentech global product development chief medical officer and head Dr Sandra Horning said: “This positive outcome in GCA, a condition for which there have been no new treatments in more than 50 years, demonstrates Genentech’s commitment to helping patients with unmet needs.
“We are pleased by the FDA’s decision to classify their review of the sBLA as priority.”
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Actemra also received priority review designation for the treatment of GCA.
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By GlobalDataThis designation was granted based on the positive outcome of the Phase III GiACTA randomised study evaluating Actemra in people with GCA.
The study was conducted in 251 patients across 76 sites in 14 countries.
FDA grants priority review designation to medicines that have been determined to have the potential to provide improvements in the safety of the treatment of a serious disease.
Genentech also received breakthrough therapy designation for the treatment of GCA with Actemra in October last year.
Breakthrough designation enables quick development and review of medicines with early evidence of substantial clinical benefit in serious diseases.
The first humanised interleukin-6 receptor antagonist Actemra has been approved to treat adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying anti-rheumatic drugs.
It is not approved for subcutaneous use in people with polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis.
Image: Histopathology of giant cell vasculitis in a cerebral artery. Elastica-stain. Photo: courtesy of Marvin 101.
