Janssen’s decision is based on results from the interim analyses of the Phase 3 clinical study of Pimodivir in hospitalised patients infected with influenza A virus
Janssen Pharmaceutica unit in Xi'an. (Credit: Vberger/Wikipedia.)
Johnson & Johnson’s pharmaceutical business arm Janssen has unveiled its plans to discontinue the clinical development of Pimodivir, its investigational drug to treat influenza A infection.
The drugmaker said that its decision is supported by results from the planned interim analyses of the Phase 3 clinical study of Pimodivir in hospitalised patients infected with influenza A virus.
The study showed that Pimodivir plus standard of care (SOC) combination is not effective for patients hospitalised with influenza A when compared to SOC treatment alone.
Janssen Research and Development infectious diseases global therapeutic area head James Merson said: “While our goal was to develop an innovative new treatment option for patients at risk of respiratory infections, unfortunately, these data show that Pimodivir does not offer a benefit above the existing standard of care.
“At Janssen, we have a deep heritage of caring for those affected by respiratory infectious diseases and will continue to do so, focusing on clinical development programs that we believe will offer transformational medical innovation to patients.”
Janssen received BARDA funding for Pimodivir development programme
The company said that the Phase 3 development programme of Pimodivir includes two Phase 3 trials, and is aimed at evaluating the safety and efficacy of Pimodivir.
The first Phase 3 trial evaluates the drug in combination with standard of care (SOC) treatment in participants hospitalised with influenza A infection, while the second one in non-hospitalised participants at risk of developing complications due to influenza A infection.
Janssen said that it is underway informing all study investigators and related health authorities of the decision to terminate the development programme, under which clinical study in hospitalised patients with influenza A and a similar Phase 3 study in outpatients with influenza A will be halted.
Also, the company said it has reached the decision after discussions with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, since BARDA offered funding for its Pimodivir development programme.