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FDA OKs Unusual Flu Drug

The Food and Drug Administration has approved an inhalant drug for the treatment of simple influenza. CBS News Health Correspondent Dr. Emily Senay reports.

Studies show that the drug, to be marketed under the name Relenza, can reduce the duration of flu symptoms by up to 36 hours. The drug is approved for prescription use by adults and by adolescents 12 years and older who have had flu symptoms for no more than two days.

The drug is taken directly into the lungs by an oral inhaler. Once in the lungs, it stops the virus from spreading to other cells.

Relenza is most effective when taken within the first 48 hours of symptoms, research suggests. The inhaler is used twice a day for five days for optimum relief.

The drug's manufacturer, GlaxoWellcome Inc., said Relenza is the first of a new class of drugs, called neuraminidase inhibitors, that attacks both type A and type B flu strains.

However, critics said the benefit of shortening a cold does not justify government approval, and earlier this year, a FDA advisory panel rejected the drug.

The panel voted 13-4 in February against recommending approval of Relenza, saying the drug helped flu sufferers only slightly. The panel requested more studies, particularly among people in nursing homes and the elderly.

Dr. Heidi M. Jolson, director of the FDA's antiviral drug product division, said approving a drug against the recommendation of an advisory committee "doesn't happen commonly" but Relenza adds a new weapon to the very limited flu-fighting arsenal. She said the need for some therapy against flu was a strong element in the decision.

"Influenza is an important public health problem, and this will provide another option for treatment," she said.

Jolson said that since the advisory committee vote last February, Glaxo has provided information to answer many of the questions raised during the panel's hearing.

"We felt we had sufficiently addressed the concerns that the advisory committee had brought up," Jolson said.

Some experts said Relenza could cause serious side effects for some patients.

"This drug should never have been approved," said Dr. Sidney Wolfe of the Public Citizen Health Research Group. "The benefits are close to zero."

Wolfe, a frequent critic of the FDA, said the action is an example of new and lower standards the agency now uses for drug approvals.

He said the drug could pose a breathing risk for asthma patients.

The FDA announcement warned that asthma sufferers might face breathing problems and recommended they be ready to use bronchodilator therapy when taking Relenza.

Dr. Michael J. Elliott of Glaxo, based in Research Triangle Park, N.C., said the drug has been tested on about 6,000 people in clinical trials. In Australian and European trials, he said, flu sufferers reported the inhaled drug shortened the duration of flu symptoms by about 1 and 1/2 days.

In U.S. studies, patients using th drug said their symptoms went away about a day earlier than those of people taking placebos. Elliott said these findings were based on the self-reporting of people involved in the clinical trials and were not proven by laboratory tests.

The American studies mean the course of a flu illness that would endure untreated for six to 10 days would last five to nine days, he said.

Influenza affects 25 million to 50 million Americans annually and is blamed for more than 20,000 deaths and about 300,000 hospitalizations. Flu incidence tends to peak in the fall and winter. Symptoms include headache, muscle aches, fever, cough and sore throats.

The drug did not prove effective in preventing the flu, the FDA found. Jolson said the drug was not indicated for use in stopping the spread of influenza in such places as nursing homes. This was an issue the advisory panel recommended be studied.

Elliott said Glaxo had not determined the price of the drug, but it is expected to be available this fall. Relenza is to be sold in 10-dose packages.

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