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US asks if 3 asthma drugs should stay on market

Posted on: Tuesday, 12 July 2005, 14:01 CDT

WASHINGTON (Reuters) - U.S. regulators will ask outside advisers on Wednesday if they agree that GlaxoSmithKline Plc's asthma drugs Serevent and Advair and Novartis AG's Foradil are safe enough to stay on the U.S. market, according to documents made public on Tuesday.

Food and Drug Administration officials also want the panel's advice on whether Foradil should carry warnings about the possibility that patients may experience acute exacerbations of asthma, a summary posted on the FDA Web site said.

Serevent and Advair -- a combination of Serevent and another drug -- come with "black box" warnings about a study showing that patients who took Serevent had a higher, albeit small, risk of life-threatening asthma attacks and deaths.

In summaries provided to the FDA, both Glaxo and Novartis said they felt the benefits of their asthma drugs outweighed the risks.

Serevent is one of five drugs singled out by FDA scientist David Graham as needing closer scrutiny during testimony before the Senate in November 2004.

Glaxo shares fell 13 cents, or less than 1 percent, to $48.25 on the New York Stock Exchange (NYSE) in midafternoon trade. Novartis shares rose 29 cents, or less than 1 percent, to $47.76, also on the NYSE.

Source: REUTERS

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