BRIEF—Two Japanese drug approvals for Otsuka – Busulfex and Rexulti

Japanese drugmaker Otsuka Pharmaceutical today announces it has received regulatory approval in Japan for a once-daily form in pediatric patients of Busulfex (busulfan) Injection 60mg.

Busulfex is a conditioning regimen administered via intravenous drip to patients prior to undergoing hematopoietic stem cell transplantation.

Approval in Japan reflects the once-daily usage pattern for Busulfex in pediatric patients and adults in other countries around the world., the company noted.

Otsuka has also received regulatory approval in Japan for an orally-disintegrating-dose (OD) form of Rexulti (brexpiprazole) tablets.

Rexulti OD 0.5mg, 1mg, and 2mg tablets will now become available in addition to the already available regular tablets in 1mg and 2mg doses.

Rexulti OD Tablets are a dose form that quickly disintegrate in the oral cavity so that it is easy to take for patients who cannot take the tablet due to difficulty in swallowing.

Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.

It received manufacturing and marketing approval in Japan for the indication of schizophrenia in 2018.