(Washington, D.C. – Insurance News and Markets) – The U.S Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) has announced the development of an experimental drug that may be used for individuals who have been hospitalized with influenza.
The drug could have a longer treatment window and be more powerful than what is currently available; if the U.S. Food and Drug Administration (FDA) approves the drug, it would be the first drug created specifically for this use, possibly the first in a new class of influenza antiviral drugs.
The ASPR Biomedical Advanced Research and Development Authority (BARDA) is ready to provide technical assistance and funding for a Johnson & Johnson company – Janssen Pharmaceuticals—to develop the drug, which is currently known by two names – JNJ-872 or VX787. The contract, announced in September, provides up to $103.5 million over a four year period, with an option for extra work (up to approximately $131 million for the total contract).
Current FDA-approved antiviral medications approved for treatment of influenza are typically more effective in the first 48 hours of symptoms, but studies of the experimental medication note that JNJ-872 could be effective much later.
“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.”
The drug works differently than other antiviral drugs currently available and that could be important as new drug resistant influenza strains emerge. The goal is to create a drug that can be used for high-risk patients, as well as those who are hospitalized with influenza. The late stage clinical development of this drug includes phase 3 studies in high risk populations and is expected to lead to submission of a new drug application to the FDA.
Janssen is also exploring the potential of a new way to manufacture the drug, called continuous manufacturing, which does not include the interruptions throughout the process, as the traditional manufacturing process requires.
“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.
Source: U.S. Department of Health & Human Services.