After long fight, Roche to release all Tamiflu drug data

LONDON, April 4 (Reuters) - After a lengthy fight, Swiss drugmaker Roche Holding AG said it had agreed to hand over data from all clinical trials of its best-selling flu drug Tamiflu to a group of outside researchers.

Tamiflu has been approved by regulators worldwide and stockpiled by many governments in case of a pandemic, but some scientists claim there is little evidence it works and have lobbied since 2009 for Roche to release all its trial data.

Sales of the drug hit close to $3 billion in 2009 due to the H1N1 swine flu pandemic, although they have since declined.

In an email to the Cochrane Collaboration, a non-profit group that reviews trial data to assess the value of drugs, Roche said it would provide clinical study reports on all the 74 studies into its medicine, over the next few months.

A copy of the April 2 email was supplied to Reuters on Thursday.

Roche said it would edit the study reports to ensure patient confidentiality and protect legitimate commercial interests, adding that handing over the information would take time since some of the reports ran to thousands of pages.

Campaigners who have been pushing pharmaceutical companies to be more open said they were pleased Roche had finally done the right thing, although they argued it should not have delayed access to the data in the first place.

"It shouldn't have taken the researchers years of persistence and publicity to get these Tamiflu results," said Sile Lane, director of campaigns at Sense about Science.

The Cochrane group gave Roche's move a cautious welcome but its researchers said they were still concerned that editing of the data and other problems might make analysis and interpretation difficult.

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FDA approves Roche's Tamiflu for infants with new flu symptoms

Dec 21 (Reuters) - The U.S. Food and Drug Administration on Friday expanded the use of Tamiflu, the flu drug from Roche , to children as young as two weeks old who have shown flu symptoms for no more than two days.

The FDA said the drug cannot be used to prevent flu infection in this age group. The drug is currently approved as both a flu treatment and preventative flu drug for children ages 1 and older, and adults. It aims to help lessen the length and severity of the flu.

Tamiflu was approved in 1999 and is distributed in the United States by Genentech, part of Roche. It was co-developed by Gilead Sciences. Its most common side effects include vomiting and diarrhea.

The FDA said its expanded use is based on extrapolating data from previous study results in adults and older children, and supporting studies by the U.S. National Institutes of Health and Roche.

Tamiflu, which had peak sales of $3 billion in 2009 because of the H1N1 swine flu epidemic, is approved by regulators worldwide but some researchers claim there is little evidence it works and have asked Roche to hand over data so they can study its effectiveness.

(Reporting By Caroline Humer; Editing by Grant McCool)

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FDA approves Tamiflu for children 2 weeks and up

WASHINGTON -- Children as young as 2 weeks old can take Roche's Tamiflu for flu symptoms, the Food and Drug Administration said Friday.

The FDA approved the drug for babies who have had had flu symptoms for no more than two days. Regulators stressed that the drug is not approved as a preventive measure against flu in children that young. It is also not approved to treat flu in children younger than 2 weeks old.

The FDA had already approved the drug for adults and children ages 1 and older who have shown flu symptoms for no longer than two days.

The agency said doctors must calculate the dosing for Tamiflu in patients younger than 1 based on their exact weight. These children should receive 3 milligrams of Tamiflu per kilogram twice daily for five days.

Tamiflu is distributed by Roche's South San Franscisco-based unit, Genentech.

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