REFILE-UPDATE 1-Rasilez blood pressure pill gets EU warning

Thu Feb 19, 2009 12:20pm EST
 
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LONDON, Feb 19 (Reuters) - Novartis AG's (NOVN.VX) blood pressure pill Rasilez should carry a warning that people who have developed swelling of the tissues beneath the skin after taking the drug in the past should not use it, European regulators said on Thursday.

In rare cases the condition known as angioedema can be dangerous if it affects the throat, making it difficult to breathe. The drug is sold as Tekturna in the United States.

High blood pressure affects nearly one in four adults worldwide. While is easy to measure and can be successfully managed, nearly 65 percent of patients with high blood pressure do not have the condition under control.

Rasilez, a first-in-class renin inhibitor, has been authorized in the European Union since August 2007.

In July, Novartis said it planned to buy its research partner, Swiss biotech company Speedel (SPPN.S) for about $880 million to speed up development of the potential blockbuster blood-pressure drug.

The company has been keen to shore up its franchise in treating high blood pressure as its top-selling Diovan faces generic competition when it loses exclusivity in 2012.

Rasilez was the first Speedel drug to reach the market and was co-developed with Novartis.

 

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