FDA nod for Invega Hafyera in schizophrenia, dosed twice yearly

The US Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic Invega Hafyera (six-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults, developed by Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary.

Other long-acting injectable antipsychotics are administered every few weeks to every three months. Invega Hafyera’s less frequent dosing intervals may offer more convenience for patients, caregivers, and providers, the FDA noted.

"Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods," said Bill Martin, global therapeutic area head, neuroscience, at Janssen Research & Development, adding: "Today's approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication."