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New Hypertension Drug Wins FDA Approval

old by the Swiss-based Actelion. Both drugs are so-called endothelin receptor antagonists, which work by relaxing blood vessels. The drug Thelin, developed by the Houston-based Encysive, works the same way.

As it happened Encysive Pharmaceuticals learned yesterday that its drug would not be approved yet.

The F.D.A. had recommended instead another clinical trial to prove the drugs efficacy.

This is the third time the F.D.A. has declined to give the go-ahead to Thelin, which is approved in Europe and Canada. Because of the multiple delays, Encysive lost a big lead over Gilead in the race for approval.

Gilead said its clinical trials showed that Letairis caused fewer cases of liver damage than Actelions drug. Nevertheless, the F.D.A., warning about liver damage and birth defects, is requiring Gilead to control carefully the distribution of the drug. Patients who use it are supposed to have blood tests for liver damage every month.

Gilead said Letairis, a once-a-day pill, will cost $3,940 a month, about the same as Tracleer, which is also known as bosentan. The company said it was establishing programs to help uninsured or underinsured patients obtain the drug.

The available drugs, including Letairis, can improve the ability of people to perform daily chores but do not restore normal health. In clinical trials Letairis improved the distance people could walk in six minutes by an average of 20 to 60 meters, or roughly 5 percent to 20 percent. The drug also slowed the disease.

The approval of Letairis was announced after the close of trading. Gileads shares rose 19 cents, to $80.83, in regular trading and then more than $1.50 after hours. Encysive shares fell 50 cents, to $4.10, in regular trading and another 25 cents after hours.


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