Manufacturing and marketing approval in Japan for Joyclu

Japanese firms Ono Pharmaceutical (TYO: 4528) and Seikagaku Corp (TYO: 4548) have announced that Seikagaku has obtained manufacturing and marketing approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) for Joyclu (diclofenac etalhyaluronate sodium; ONO-5704/SI-613) 30mg Intra-articular Injection for the indication of osteoarthritis (knee joint and hip joint).

The approval is based on the results of three Phase III clinical studies conducted with ONO-5704/SI-613 in Japan. In the confirmatory study in patients with knee osteoarthritis, ONO-5704/SI-613 group demonstrated a statistically significant improvement in WOMAC pain scores (a knee pain evaluation index, 100 mm VAS scale) over 12 weeks after the initial injection (three injections every four weeks), the primary endpoint of the study, compared to an inactive placebo group. Further, the safety profile of ONO-5704/SI-613 has shown no clinically-significant concerns in the study.

Joyclu is a formulation in which hyaluronic acid and diclofenac (an anti-inflammatory drug) are chemically bound using Seikagaku’s own proprietary technology. It is designed to release diclofenac by hydrolysis in the joint. Further, since Joyclu is administered directly into the joint cavity as an injectable treatment, systemic exposure to diclofenac is low, and the risk of systemic adverse drug reaction is thought to be low. Joyclu is the first joint function improvement agent in Japan indicated for the treatment of osteoarthritis of the hip joint.