Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced receiving marketing approval from the European Commission (EC) for Rxulti (brexpiprazole). The atypical oral antipsychotic can now be used to treat schizophrenia in adolescents aged 13 years and older in the European Union (EU).
Background and Development
Originated by Otsuka Pharma, brexpiprazole is co-developed and commercialized by Lundbeck through a licensing deal. The drug was previously approved by the EC for use in adults with schizophrenia in 2018.
Mechanism of Action
Rxulti achieves antipsychotic effects by regulating the serotonin and dopamine systems. It combines partial excitatory activity on serotonin 5-HT1A receptors, partial excitatory activity on dopamine D2 receptors, and antagonistic activity on serotonin 5-HT2A receptors, with similar high affinity on these receptors.
Market Implications
This approval marks a significant expansion for Rxulti, as it now addresses a critical treatment need for adolescent patients with schizophrenia in the EU. The drug’s unique mechanism of action offers a valuable addition to the treatment landscape for this condition.-Fineline Info & Tech
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