FDA Announces Label Expansion for Treprostinil to treat Pulmonary Arterial Hypertension

According to a story from MDMag, the US Food and Drug Administration (FDA) has recently approved a label expansion for the drug treprostinil (marketed as Orentiram). This update to the label now approves the drug as a treatment for pulmonary arterial hypertension, a rare condition that affects the lungs. The drug was developed by United Therapeutics. The label calls for the use of treprostinil combined with another medication in order to delay progression of the disease.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplant. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.

Clinical Findings

The label expansion follows encouraging results in the clinical trial setting. In the trial, patients that received treprostinil as a supplement to another orally administered monotherapy saw significantly delayed progression of their disease in comparison to placebo. Disease progression was defined as a “clinical-worsening event.” Risk of disease progression was reduced by an average of 61 percent. 

Same Disease, New Purpose

Treprostinil was originally approved for the treatment of pulmonary arterial hypertension in 2013, but at that time the perceived benefit of its use was capacity for exercise, and the drug was taken on its own. This new expansion will allow the drug to be used alongside other treatments and have a greater impact on the lives of patients.

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