JW Pharmaceutical Expands Rare Indication for Rheumatoid Arthritis Treatment 'Actemra'

[Asia Economy Reporter Cho Hyun-ui] JW Pharmaceutical announced on the 1st that its rheumatoid arthritis treatment 'Actemra Subcutaneous Injection' (generic name tocilizumab) has received approval from the Ministry of Food and Drug Safety for the indication of treating giant cell arteritis.

Giant cell arteritis is a chronic inflammatory disease characterized by inflammation and necrosis of the inner walls of arteries that supply blood from the heart to the entire body.

This approval was based on the results of a Phase 3 clinical trial (GiACTA) demonstrating the efficacy and safety of Actemra subcutaneous injection in patients with active giant cell arteritis.

According to a study conducted by Dr. John H. Stone's research team at Massachusetts General Hospital, Harvard Medical School, involving 251 patients over 52 weeks starting July 2013, 56% of patients receiving weekly or biweekly Actemra injections at week 52 achieved 'sustained remission.' In contrast, only 14% of the placebo group reached this outcome.

Comparing cumulative steroid use, the Actemra group and placebo group recorded 1862 mg and 3296 mg respectively, confirming that steroid usage could be reduced.

A JW Pharmaceutical official stated, “Actemra subcutaneous injection is the only biologic agent that can reduce steroid use and improve the quality of life for patients with giant cell arteritis,” adding, “Following approvals in the United States and Europe, receiving approval domestically is hopeful news for patients who had poor prognoses with existing treatments.”

This content was produced with the assistance of AI translation services.