H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. have announced that the European Commission has approved Rxulti (brexpiprazole) for the treatment of schizophrenia in adults.
The approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on May 31, 2018.
Expected in the EU 2019
Lundbeck and Otsuka will now work with local pricing and reimbursement bodies in countries throughout Europe to help ensure that eligible patients are able to access Rxulti. The medicine is expected to be made available in the first EU markets during first half of 2019.
Brexpiprazole is a once-daily second generation (atypical) oral antipsychotic; it provides a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits affinity for these receptors as well as for noradrenaline alpha1B/2C receptors. Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.