Roche Group subsidiary Genentech has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Actemra (tocilizumab) to treat patients with systemic sclerosis (scleroderma).
Systemic sclerosis is a rare and chronic disorder, which is characterised by blood vessel abnormalities and degenerative changes, as well as scarring in the skin, joints and internal organs.
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Actemra is claimed to be the first humanised interleukin-6 (IL-6) receptor antagonist that is approved to treat adult patients with moderately to severely active rheumatoid arthritis (RA).
In addition, Actemra is used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older.
Genentech global product development head and chief medical officer Dr Sandra Horning said: “The development of Actemra in systemic sclerosis represents our commitment to severe rheumatic diseases.
“This breakthrough therapy designation underscores the unmet need in systemic sclerosis and the potential of Actemra to help patients with this debilitating autoimmune disorder.”
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By GlobalDataThe breakthrough therapy status was provided based on the firm’s 48 week data from the Phase II faSScinate study.
According to the firm, the primary endpoint of improvement in skin thickening at 24 weeks was not met as assessed by the Rodnan skin score, while in the second part of the study there was continued improvement in skin thickening between weeks 24 and 48.
The company started multicentre, randomised, double-blind and placebo-controlled Phase III trial (NCT02453256), based on the Phase II results and the unmet need in patients with systemic sclerosis.
Image: One of the newest buildings on Genentech’s headquarters campus in South San Francisco. Photo: courtesy of Coolcaesar.
