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European Commission Grants Approval For Johnson & Johnson's Twice-yearly Schizophrenia Drug

The European Commission has approved BYANNLI, a 6-monthly paliperidone palmitate, developed by The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), for the maintenance treatment of schizophrenia in adults who are clinically stable on *1-monthly paliperidone palmitate (PP1M) or *3-monthly paliperidone palmitate (PP3M).

The approval makes BYANNLI the first twice-yearly treatment for adults living with schizophrenia to be approved by the European Commission, with the longest available dosing interval for an antipsychotic medication in the European Economic Area, according to the company.

The drug received approval in the U.S., under brand name INVEGA HAFYERA, for the treatment of schizophrenia in adults who have been adequately treated with 1-month paliperidone palmitate for at least four months or 3-month paliperidone palmitate for at least one 3-month injection cycle in September of this year.

*Johnson & Johnson's 1-monthly paliperidone palmitate (PP1M) is approved under brand name XEPLION in Europe and as Invega Sustenna outside Europe. The 3-monthly paliperidone palmitate (PP3M).is approved under brand name TREVICTA in Europe and as Invega Trinza outside Europe.

Commenting on BYANNLI,'s approval, Bill Martin, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC, said, "Today's approval of PP6M by the European Commission is a key milestone in our ongoing work towards this goal by offering patients and their loved ones the potential for a life less defined by schizophrenia medication."

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