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The FDA has granted approval to a medication for people with advanced forms of pulmonary arterial hypertension (PH). Iloprost is to be marketed as Ventavis, designed as an inhaled solution for people diagnosed with being in stage II or IV pulmonary hypertension.
PH affects an estimated 50,000 people in the United States, with 15,000 people diagnosed and prescribed treatment for the rare lung disorder. The latest FDA approval is intended as a non-invasive treatment option.
Approval was based on a randomized, double-blind, placebo-controlled clinical trial involving more than 200 people with advanced pulmonary hypertension. Half of the participants had unknown causes of PH, and the rest of the participant cases were associated with connective tissue disease, anorexigen use or chronic thromboemoblic disease.
Patients included in the study that were given Ventavis compared to those in the group given a placebo had reduced disease severity, improved walking distance and it stabilized the cases of PH. By the end of the study, patients taking Ventavis were able to walk 40 meters farther than those taking the placebo.
PH causes the blood pressure in the pulmonary artery to raise to abnormally high levels, causing symptoms such as chronic fatigue, shortness of breath, chest pain, fainting, swollen ankles and abdominal fluid build-up.
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