Government Funds Development of Single Dose Flu Antiviral
The U.S. Biomedical Advanced Research and Development Authority, BARDA, announced the $231 million, five-year contract on March 31.
A $231 million contract for five years will fund the activities needed to bring a new influenza antiviral drug to the point of FDA approval for use in the United States, the U.S. Biomedical Advanced Research and Development Authority, BARDA, announced March 31. The five-year contract with Biota Scientific Management Pty, Ltd of Melbourne, Australia, is intended to develop a drug named CS-8958, which is currently sold in Japan under the name Inavir®. A single dose is the full treatment.
Current FDA-approved antivirals oseltamivir (Tamiflu®) and zanamivir (Relenza®) require five days of twice daily dosing, according to HHS. BARDA is an agency within the Office of the Assistant Secretary for Preparedness and Response in HHS.
With the Japanese firm Daiichi Sankyo, Biota co-owns a range of second-generation influenza antivirals, of which Inavir is the lead product; Inavir is Daiichi Sankyo's registered brand for laninamivir octanoate, according to Biota.
"This award represents another critical step forward in ensuring that safe and effective antiviral drugs are available for the treatment of influenza," said BARDA Director Dr. Robin Robinson. "The ability to treat influenza by delivering a single dose of medicine would provide real advantages to doctors and patients during an emergency and would be an important addition to our pandemic influenza arsenal."
Inavir is not a vaccine. It is a long-acting neuraminidase inhibitor that prevents flu virus from spreading in the body's cells. The drug is delivered via a dry powder inhaler.
Under the contract, Biota Scientific will set up U.S. manufacturing of the drug, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. The contract is part of BARDA's implementation of the national pandemic influenza preparedness strategy, which includes accelerated development of new antivirals.