HHS Sponsors Development of Drug for Hospitalized Influenza Patients
September 28, 2015 (HHS)
Development of an experimental influenza antiviral drug that may be more potent and could have a longer treatment window than existing drugs will receive support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR). The drug is being developed for use in treating patients hospitalized with influenza.
If development is successful and the drug receives U.S. Food and Drug Administration (FDA) approval, the drug could become the first specifically for this use and potentially the first in a new class of influenza antivirals.
The ASPR Biomedical Advanced Research and Development Authority (BARDA) will provide technical assistance and funding to Janssen Pharmaceuticals Inc., one of the pharmaceutical companies of Johnson & Johnson, in Raritan, New Jersey, for advanced development of the drug, JNJ-872 (also known as VX787). The contract will provide up to approximately $103.5 million over the next four years and three months. The contract includes options for additional work up to a total of approximately $131 million.
While other FDA-approved influenza antiviral medications are usually more effective if given within 48 hours of symptom onset, studies of JNJ-872 to date suggest that the experimental drug may provide clinical benefits when administered much later than 48 hours after symptoms begin.
"Typically patients are not hospitalized within 48 hours of developing flu symptoms, so doctors and their patients need treatment options that are effective later in the course of illness," explained BARDA Director Robin Robinson, Ph.D. "This is a critical health priority as tens of thousands of flu patients are hospitalized each year in the United States and that number can be even higher in a pandemic."
JNJ872 may represent an entirely new class of influenza antiviral drugs that has a unique mechanism of action, meaning that the drug works through different mechanisms than currently available antiviral drugs. Having unique mechanisms of action may be important as influenza viruses emerge that are resistant to current antivirals drugs, particularly influenza viruses with potential to become pandemics.
BARDA's goal in supporting JNJ872 is development of a product that can be used not only to treat hospitalized influenza patients but also to treat patients for whom influenza poses high risks, such as the elderly, pediatrics, and those with chronic conditions such as COPD and heart disease, and for use specifically in treating patients who have been hospitalized with influenza.
The BARDA-supported late stage clinical development of JNJ872 includes pivotal phase 3 studies in high risk populations and hospitalized patients, as well as final development of a validated commercial-scale manufacturing process. The BARDA-sponsored work is expected to lead to the company's submission of a new drug application to the FDA for potential approval.
In addition, Janssen, in consultation with BARDA, will explore the feasibility of an innovative approach to manufacturing called continuous manufacturing for JNJ872 and for potential use in future Janssen products. Traditional drug manufacturing requires interruptions at multiple stages of the manufacturing process. In contrast, continuous manufacturing allows for the continuous flow of materials throughout the manufacturing process.
"We're interested in manufacturing innovation as part of medical countermeasure development to be as agile, efficient and cost-effective as possible, and continuous manufacturing has that potential," said Dr. Robinson.
The new antiviral drug development project is part of BARDA's comprehensive integrated portfolio approach for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to pandemic influenza, these threats include chemical, biological, radiological, and nuclear agents, emerging infectious diseases, and antimicrobial resistance.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, phe.gov. Information about influenza is available atflu.gov.