Glaxo gets FDA approval for flu drug Relenza to be marketed in the U.S.
URL: cbs.marketwatch.com
By Barbara Kollmeyer, CBS MarketWatch
Last Update: 11:07 AM ET Jul 27, 1999 NewsWatch
LONDON (CBS.MW) -- Shares in Glaxo Wellcome, the British pharmaceutical giant, were higher on Tuesday after the company said it's received U.S. Food and Drug Administration (FDA) approval for its flu drug, Relenza.
The approval follows an extensive regulatory review period after an initial application by Glaxo (GLX: news, msgs) in February 1999. Relenza, known as zanamivir in its generic terms, can now be marketed for the treatment of influenza A and B in the U.S.
The news boosted Glaxo shares which rose 79 pence or 5 percent to 16.85 pence towards the end of London's trading day on Tuesday.
Relenza is already marketed in Australia and New Zealand and has had widespread approval in the European Union and Switzerland. Analysts said the U.S. marketing of the drug could net the company between $500 million and $1 billion.
A spokesman for Glaxo told CBS.MarketWatch.com that it was too early to tell how much money the drug had made in Australia and New Zealand as those launches are in the early stages. But he said patient feedback on the drug so far has been "extremely positive."
Relenza is the first of a new class of drugs called neuraminidase inhibitors and is administered using an inhaler. It prevents infection from travelling from one cell to another within the respiratory tract, the chief site of viral replication.
The fact that the drug is inhaled and not taken in pill format cuts down on potential side effects, as the drug isn't absorbed into the body, said Glaxo. It said the drug was found to have a high safety profile, equivalent to receiving an inhaler not loaded with the drug, or what is known as a placebo effect.
In clinical trials involving more than 6,000 patients, Glaxo said Relenza was found to have cut flu symptoms significantly.
Barbara Kollmeyer writes for CBS MarketWatch in London.
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