Research Triangle Park-based BioCryst won U.S. Food and Drug Administration approval Monday to begin selling a new intravenous drug for treating flu.
The drug, Peramivir, will be sold in the United States under the brand name Rapivab. Company officials said it’s the first new flu drug to be approved in 15 years.
Peramivir had gained approval in Japan and Korea, and while still in trials, it received limited FDA authorization in emergency cases. The announcement on Monday, though, marked the 28-year-old company’s first full FDA approval for a drug, and BioCryst executives were in a celebratory mood.
“This is a really historic event for this company,” said Jon Stonehouse, BioCryst’s CEO. “There aren’t that many companies that actually discover a drug, develop it and get it approved, and it’s just great to see another North Carolina company get into that category.”
The approval was timely, as the flu season has accelerated in recent weeks and pharmacies here and in other states have reported shortages of Tamiflu, the most commonly used treatment for reducing the impact of a flu infection.
BioCryst had built up supplies of Rapivab in anticipation of the FDA approval and will begin shipping almost immediately, Stonehouse said. They should be available in North Carolina and elsewhere within a matter of days.
“Our goal, even with the holidays, is to have it in our distributor’s hands this week,” he said.
The federal government paid the company $235 million to develop the drug and is expected to buy a large supply for a national stockpile to use in case of a pandemic.
Stonehouse said Monday that federal officials wanted to wait for the drug to gain FDA approval before formally discussing a large purchase but that he expected contract negotiations to start soon.
For adults only
Rapivab is aimed at severe cases and is recommended only for use in adults and within the first two days of an infection. It works by attacking an enzyme that releases the virus from cells after they are infected, allowing it to spread and infect other cells.
Two other drugs on the market work in similar fashion: Tamiflu, which is administered orally, and Relenza, which is inhaled. Among the differences are that the two older drugs can be used on children. They also require patients to receive a course of multiple doses, while Rapivab is administered with a single IV dose.
That will make it attractive in cases where a doctor feels a patient would be better off having one immediate dose, said the pharmaceutical company’s chief medical officer, Bill Sheridan.
It also will be helpful in cases where a patient is vomiting and might not be able to use an oral drug or who has respiratory issues that prevent using an inhaled one, Stonehouse said.
In a trial of 297 flu patients, some received what is regarded as a half dose of Rapivab, a full dose or a placebo. According to an FDA news release on the drug’s approval, those who got a full dose had their symptoms end an average of nearly a full day sooner than those who got the placebo.
That result is similar to studies of similar competing drugs.
The drug is being made in the United States, but not in North Carolina, Stonehouse said.
The company has several other drugs in earlier stages of development, including an antiviral that could work on the deadly Ebola and Marburg viruses.
That drug, which is being developed with $24.4 million from the National Institute of Allergy and Infectious Diseases, entered an initial trial a few weeks ago.