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Seikagaku and Ono Submit NDA for Injectable OA Treatment in Japan -

Seikagaku and Ono Pharmaceutical submitted a new drug application for manufacturing and marketing approval for ONO-5704/SI-613 injectable in Japan for the treatment of osteoarthritis in the knee, hip and ankle. The NDA is based on the results of three Phase III clinical studies conducted in Japan. ONO-5704/SI-613 is a combination of hyaluronic acid (HA) and an NSAID to address pain and inflammation through a 3-injection regimen. Ono and Seikagaku formed a preliminary collaboration to co-develop and market the product in 2Q17, which became a definitive agreement later in the year. In a confirmatory study in 440 patients with knee osteoarthritis, the product demonstrated a statistically significant improvement knee pain evaluation index scores at 12 weeks after the initial injection (three injections every four weeks), a primary endpoint of the study, compared with a placebo.