U.S. government has spent $34 million to help Biota test the drug with hopes of winning approval to bring it to market in the United States. The government had agreed to spend up to about $231 million on the project over five years. But last week a federal official said a review found “significant challenges” that could cause delays and cost increases in the work. Biota’s contract is through the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services.
A BARDA official said last week that the agency does not have safety worries about the drug, laninamivir octanoate, but that concerns had arisen about the enrollment of subjects in clinical trials, the cost of additional trials, the “emergence of resistance to laninamivir in recent H7N9 virus strains, and the feasibility of laninamivir for treatment of critically ill, hospitalized patients with influenza.”