US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia
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 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."
Pricing of Invega Hafyera
According to a Janssen spokesman, the drug will cost between $11,760.28 and $17,640.05, which is “comparable” to its other long-acting injectables. The company expects most patients will likely pay no more than $10 per month. To be eligible for the drug, patients must have previously received four doses of a once-a-month version of paliperidone palmitate, or one dose of a thrice-monthly formulation.
Clinical backing
The efficacy of Hafyera was evaluated in a randomized, double-blind, active-controlled study in 702 adults with schizophrenia who had previously been stably treated with either Invega Sustenna, a one-month extended-release injectable suspension of paliperidone palmitate, for at least four months, or Invega Trinza, a one-time three-month extended-release injectable suspension of paliperidone palmitate.
The study was a non-inferiority trial designed to evaluate whether the time to relapse for Hafyera administered once every six months provided similar effectiveness as Trinza administered every three months. Among the treatment groups, 7.5% of patients in the Hafyera group experienced a relapse whereas 4.9% of patients in the Trinza group experienced a relapse. The difference between groups within the non-inferiority margin supports the effectiveness of Hafyera.
Schizophrenia is a brain disorder characterized by symptoms including delusions, hallucinations, trouble with thinking, and lack of motivation. Schizophrenia affects less than 1% of the US population. It is a chronic disorder, but symptoms can decrease with treatment.
On average, an adult with schizophrenia experiences nine relapses in less than six years, often due to missed doses of medication. In addition, patients who experience more relapses may have more hospitalizations, which can lead to higher medical costs for patients, hospital systems, and payers.