BioCryst Pharmaceuticals announced Monday that the Food and Drug Administration has approved its intravenous flu treatment peramivir.
It is the 24-year-old Durham company’s first drug to win approval in the U.S. Peramivir is already approved in Japan and Korea.
Peramivir’s approval was delayed earlier this year after the FDA expressed concerns about the contract manufacturer that was to produce the treatment.
Peramivir was developed under $235 a million contract with the federal government.
Peramivir delivers high plasma doses to infected areas, and is the first IV antiviral approved in this country. BioCryst has said peramivir is effective against multiple flu strains, including the H1N1 swine flu.
BioCryst’s stock is now up nearly 47 percent for the year. It closed Friday at $11.16.
Earlier this month BioCryst announced the dosing amounts for the first human trial of the company's experimental antiviral, BCX4430.
The drug is being developed with federal funding against Ebola and Marburg virus diseases, both of which have high fatality rates. It will be tested on up to 88 healthy volunteers for safety and tolerability only, not for effectiveness.
The study is funded by the National Institute of Allergy and Infectious Diseases, one of the National Institutes of Health.