FDA approves new flu drug

HELP AT HOME: Suffering from the flu? These tips can help nurse you back to health. FLU: description risk symptoms treatment prevention Choose a link above to learn more about flu. Source: WebMD

July 27, 1999
Web posted at: 12:38 p.m. EDT (1638 GMT)

WASHINGTON (CNN) -- The U.S. Food and Drug Administration Tuesday approved a new drug for treating some cases of the flu.

The drug zanamivir is being marketed by drugmaker Glaxo Wellcome as Relenza. It's inhaled through the mouth with a plastic device the company calls a Diskhaler.

Relenza is the first drug approved for treatment of the flu since rimantadine in 1993.

Studies show taking Relenza twice daily for five days cut the duration of flu symptoms by one to two days. But to be effective, the drug must be administered soon after flu symptoms start. The FDA said that in clinical trials, the drug helped only patients who started treatment within two days after starting to feel sick.

Relenza appears to be less effective in patients who do not have an elevated temperature or severe flu symptoms.

Dr. Arnold Monto with the University of Michigan said the drug is important because it fights both strains of influenza.

"I think this will make a major change, because we will have a drug for flu treatment, which will be effective and which will work against both type A and B," Monto said.

Drugs currently on the market work against only influenza A.

Study participant Elizabeth Zolowicz said Relenza worked well for her.

"I felt great, I really did. I took it at about midnight the first time. By morning the fever was gone, and I was so much better," Zolowicz said.

A recent study showed Relenza also prevents the flu just as well as a flu shot. Glaxo Wellcome plans to seek FDA approval to use the medication for flu prevention by the end of the year.

An FDA advisory committee had voted against Relenza in February, saying the drug was not effective enough, knocking only a day and a half off a bout of flu. The FDA does not usually approve a drug against the advice of an advisory committee, but because flu costs Americans so much in lost productivity, it did.

Relenza is expected to be on pharmacy shelves by this fall in the United States. The drug already is marketed in Australia and New Zealand. The company said it has been approved in all 15 European Union countries and Switzerland.

Relenza is approved only for patients 12 and older. Asthma sufferers are being warned the drug could cause bronchial spasms.

Medical Correspondent Rhonda Rowland contributed to this report.