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New Hypertension Drug Wins FDA Approval

The US based drug manufacturers Gilead Sciences have won FDA approval for a new drug to treat a life-threatening lung disease. Key words: pulmonary arterial hypertension, liver injury, birth defect risks, death, heart failure, breath, rare disease, impotence pill, Viagra, endothelin, receptor, antagonists, relaxing, blood vessels, ambrisentan, Letairis. US-based biotechnology company Gilead Sciences said late Friday that the Food and Drug Administration (FDA) approved 5-milligram and 10-milligram tablets of its hypertension drug Letairis.

The drug, also called ambrisentan, is a once-daily treatment for pulmonary arterial hypertension.

Because of liver injury and birth defect risks, the drug will be available through the Letairis Education and Access Program, a restricted distribution program aimed at helping patients learn about the risks involved.

Pulmonary arterial hypertension is marked by extremely high blood pressure in the arteries that supply blood to the lungs. That makes it hard for people to breathe or exert themselves. It also puts a strain on the heart that eventually leads to heart failure and death. The disease affects about 100,000 Americans, according to the FDA.

It can cause severe shortness of breath and heart failure and, if untreated, leads to death in about three years, Gilead said.

The approval of Letairis is a big step in an effort by Gilead, one of the largest biotechnology companies, to diversify beyond its successful drugs for H.I.V. and AIDS into drugs for heart and lung diseases. Its AIDS drugs accounted for about 70 percent of its $3 billion in revenues last year.

Although pulmonary arterial hypertension is a fairly rare disease, there are already several treatments available for it, including Pfizers Revatio, which contains the same ingredient as its impotence pill, Viagra.

Gileads Letairis is likely to compete most directly against Tracleer, a drug s
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