US asks if 3 asthma drugs should stay on market

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.