JW Pharmaceutical said Tuesday that its rheumatoid arthritis drug, Actemra (ingredient: tocilizumab), has won approval from the Ministry of Food and Drug Safety to treat giant cell arteries (GCA).
GCA is a chronic inflammatory disease causing infection and death of the arteries' inner wall that supply blood throughout the body from the heart. The disease is also known as temporal arteritis, as it mainly occurs in the arteries of both sides of the head.
|JW Pharmaceutical’s rheumatoid arthritis therapy, Actemra, has won approval from the Ministry of Food and Drug Safety to treat giant cell arteries. (JW Pharma)|
It accompanies constitutional symptoms, such as headache, masticatory muscle claudication, vision loss, multiple rheumatic muscle pain and fever.
The regulatory nod was based on the results of phase 3 clinical trials, Giant-Cell Arteritis Actemra (GiACTA), which proved the efficacy and safety of Actemra injection in patients with active GCA.
A research team led by Dr. John H. Stone at Massachusetts General Hospital, which is affiliated with Harvard Medical School, conducted trials on 251 patients for 52 weeks from July 2013. At 52 weeks of the study, the Actemra cohort reached 56 percent of sustained glucocorticoid-free remission, while the control group stood at only 14 percent, demonstrating a significant therapeutic effect of the drug.
"Actemra subcutaneous injection is the only biological agent that can improve GCA patients' quality of life by lowering the use of steroids," a JW Pharmaceutical official said. "The recent approval will be promising news for those who have had a poor prognosis with the existing treatments, as Korea has approved Actemra following the U.S. and Europe."
Actemra is an effective antibody therapy for treating interleukin-6 (IL-6)-related diseases, such as rheumatoid arthritis, by inhibiting the IL-6 from binding to the receptors, the official noted.
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