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UPDATE 1-Actelion's Tracleer gets US approval for wider use

Mon Aug 10, 2009 11:07am IST
 
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* U.S. approval for early pulmonary arterial hypertension

* New formulation of Ventavis also approved

(Adds details, background)

ZURICH, Aug 10 (Reuters) - Europe's biggest biotech company Actelion Ltd (ATLN.VX: Quote, Profile, Research) said on Monday its Tracleer drug had been granted approval for mildly symptomatic pulmonary arterial hypertension (PAH).

The drug is already approved for patients with advanced, or functional class III and IV PAH. Actelion said it was working with authorities worldwide to expand the label to patients with functional class II PAH.

Actelion is trying to cut its dependence on Tracleer, which treats heart and lung disease and generates revenue of more than $1 billion a year, by developing it in new indications and pushing other new drugs to market.

Separately, Actelion announced that the U.S. Food and Drug Administration has approved a 20 microgram per millilitre formulation of Ventavis for Class III and IV PAH.

It said the increased strength formulation would deliver the same dose in half the volume, which should reduce inhalation time.

For full statements, click [ID:nHUGBWVSVa] [ID:nHUGBWQXTa] (Reporting by Emma Thomasson, editing by Will Waterman)

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