
Chugai receive orphan drug status for autoimmune disease treatment
pharmafile | March 17, 2016 | News story | Manufacturing and Production, Medical Communications, Research and Development |Â Â chuagi, systemic scleroderma, tocilizumabÂ
Chugai Pharmaceutical Co. (TYO: 4519) has received a notification of orphan drug designation, from the Japanese minister of health, labour and welfare, for tocilizumab which is a drug under development for treatment of systemic scleroderma.
Under Japanese law, this status will grant the drug priority review for fast track to approval if positive effects can be proven.
Systemic scleroderma is an autoimmune or connective tissue disease that is characterised by thickening of the skin caused by accumulation of collagen, and by injuries to the smallest arteries. Skin hardening can often be followed by internal organs being adversely affected. No established treatment has yet been put in place, with current therapeutic options limited to corticosteroids and immunosuppressants.
Chugai has been in engaged in the clinical development of tocilizumab as an effective treatment for systemic scleroderma with Roche. Tocilizumab is a anti-human IL-6 receptor monoclonal antibody that seeks to block the interleukin 6 cytokine relevant to many inflammatory diseases. A Phase III trial on its use to treat systemic scleroderma is underway following positive results from the Phase II trial announced in February.
Dr. Yutaka Tanaka, Chugai’s director and executive vice president, comments: “Systemic scleroderma is a refractory chronic disease with limited therapeutic options and high unmet medical needs. Thus healthcare providers and patients have been waiting a long time for a new drug. In order to be of some help for them, we are committed to develop and obtain early approval of tocilizumab.”
Sean Murray
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