FDA Approves BioCryst’s Rapivab Influenza Drug

BioCryst said it would start shipping its influenza drug Rapivab following FDA approval of the first new antiviral flu therapy in 15 years.

Rapivab (peramivir) is indicated as a single injection to treat adults who have shown symptoms of uncomplicated influenza for no more than two days. Two other drugs exist in its class, one that is inhaled and the other that is oral.

Many influenza patients experience both vomiting and respiratory symptoms, which might make it difficult to either swallow or inhale a drug, Jon Stonehouse, BioCryst’s president and CEO, said.

Another concern with existing therapies is that many patients don’t take their medications properly once they return home, he said. With Rapivab, doctors can easily administer the single intravenous dose at the hospital, Stonehouse added.

The drug won approval based on 27 clinical trials of roughly 2,700 patients in which subjects treated with one dose of the drug had symptoms disappear 21 hours sooner than did patients on placebo. BioCryst originally tested Rapivab both for uncomplicated influenza and for hospitalized influenza patients, but was forced to pull the second indication after disappointing Phase III data.

BioCryst received support for the drug from the Biomedical Advanced Research and Development Authority, a federal program dedicated to developing treatments for use in public health emergencies. — Lena Freund