ONO Pharma submits Onoact for additional indication in Japan

Japanese drugmaker ONO Pharmaceutical (TYO: 4528) said today that it has submitted an application on its Onoact (landiolol hydrochloride) for intravenous infusion, a short-acting selective β1 blocker for the additional indication of tachyarrhythmia (atrial fibrillation, atrial flutter and sinus tachycardia) associated with sepsis in Japan.

This application is based on the result of a multicenter, randomized, open-label, parallel-group, late Phase II/III study (ONO-1101-32), conducted in Japan, in patients with tachyarrhythmia (atrial fibrillation, atrial flutter and sinus tachycardia) associated with sepsis. Sepsis is defined as a condition that causes severe organ dysfunction due to infection.

Tachyarrhythmia may develop in sepsis patients as a result of sympathetic hyperactivity and increases in inflammatory cytokines. Onoact, discovered and developed internally by ONO, is expected to contribute to patients for the therapy of tachyarrhythmia associated with sepsis.