Gilead gets FDA OK on Letairis      

            FOSTER CITY , CA - Gilead Sciences Inc. received U.S. Food and Drug Administration (FDA) approval for its drug Letairis to treat a lethal form of hypertension that strikes without warning and can kill within three years if untreated. The drug is designed to treat pulmonary arterial hypertension (PAH), in which arteries in the lungs constrict and thicken, raising blood pressure and eventually causing heart failure.

Patients typically complain of exhaustion, breathlessness, and inability to walk distances or perform activities of normal daily living. Often, no cause can be identified, although the condition can be triggered by diseases like scleroderma or advanced HIV, or by certain medicines like the diet drug combo Fen-Phen.

            Letairis is in a class of drugs called ERAs, or endothelin receptor antagonists, compounds that relax the vessels, lowering blood pressure and lightening the load on the heart and lungs. However, such drugs can't be taken by pregnant women due to risk of major birth defects, and can cause liver damage. In studies, the drug improved patients exercise capacity, measured by a six-minute walking distance test.

Gilead said it has priced the drug at $3,940 a month, comparable to other oral drugs for the disease. Gilead said it established a program to ensure greater access to patients who are underinsured or face high co-payment requirements.

Due to the risks of liver damage and birth defects, the label will carry strong cautionary language in a black box, as do other drugs of its class. Gilead said its studies show incidence of liver damage is less with Letairis than with other products in this class, and that Letairis will be available only through a special restricted program to educate patients and doctors about safe usage.