In what BioCryst President and CEO Jon Stonehouse called a “great day for North Carolina biotech,” the Durham company is leading a celebration for U.S. Food and Drug Administration approval of its intravenous flu treatment, RAPIVAB.
The drug, already marketed as Peramivir in Japan and Korea, will soon be the first new drug on the United States market to treat existing flu infections.
It comes just six months after FDA approval of Novartis’ breakthrough Flucelvax flu vaccine biomanufactured in Holly Springs.
Monday’s BioCryst announcement was not only a cheer for the company, but also a stark reminder of the long and expensive route from discovery to market for new therapies. BioCryst was started 28 years ago, and this marks its first full FDA approval for a drug.
“The approval of RAPIVAB provides a new choice to immediately deliver an effective treatment in one dose to adult patients with influenza,” said Stonehouse. He expressed gratitude for the $235 million in federal funding that helped bring the drug through the pipeline to get the FDA stamp of approval.
“This is the first U.S. approval of a BioCryst discovered drug and represents an important milestone for our company. We thank our funding partner BARDA/HHS; the development and approval of RAPIVAB is an excellent example of a successful public/private partnership.”
BioCryst also has several other drugs in various stages of development, including one that is being explored as an Ebola treatment with the help of a $24.4 million grant from the National Institute of Allergy and Infectious Diseases.
(C) N.C. Biotechnology Center
