FDA approves new flu medication created in Durham
DURHAM (WTVD) -- There's a new anti-viral flu medicine on the market that was discovered and developed in Durham.
It's called Rapivab, and it was cultivated by BioCryst Pharmaceuticals. Much like other anti-viral medication, like Tamiflu, it is used to treat the flu and lessen the severity and duration of symptoms. But that's where the major similarities end.
"What makes it unique, first of all, it's the first approved drug in 15 years to treat influenza. And it's the first and only one-dose IV treatment, so it's a single dose and you're done," says BioCryst CEO Jon Stonehouse.
This drug is meant for patients who are very ill and end up in an emergency room or an urgent care clinic. Rapivab is already being used in some hospitals here in North Carolina, and the company is trying to spread the word to others.
"I think the challenge we have is that normally you'd get an approval in advance of the flu season and you'd have weeks or months to be able to get the word out, get it stocked in hospitals and the like. Unfortunately, we got the approval smack-dab in the middle of the flu season around the Christmas holiday," Stonehouse explains.
This isn't the first time the drug has been on the market. During the flu pandemic of 2009, the FDA gave BioCryst an "emergency use authorization" for Rapivab.
The company sent it out to the CDC, which then sent it out to the areas where it was most needed at the time. After distribution, the company learned as many as 1,200 patients may have benefited from the IV medication.
However, after the pandemic was over, the emergency use authorization was pulled and BioCryst had to continue to wait for full FDA approval. This delay shows just how long it can take for new drugs like this to get cleared by the FDA.
Regardless of the time it took, Stonehouse says he's thrilled that it's on the market now, especially at a time when some health professionals are predicting a shortage of other anti-virals.
"Yeah, there's no shortage of Rapivab, we've been working very hard since the approval to make sure that we got the drug out into the supply channels. Right now there's...over 30,000 doses of Rapivab out in the supply chain," he says.
Rapivab is only available as an IV treatment for now, but the company isn't ruling out coming up with another form, like a pill, in the future. As is the case with other anti-viral medication, this must be taken within 48 hours of the onset of flu symptoms.
For more information and a link to the official press release concerning the FDA's approval of Rapivab:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427755.htm
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=888601
