FDA Approves Drug To Treat Pulmonary Arterial Hypertension

The FDA approved Opsumit, a drug to treat pulmonary arterial hypertension, a progressive disease that can require a lung transplant and can even prove fatal.

Pulmonary arterial hypertension (PAH) is a form of hypertension where the arteries of lungs constrict, making the heart work harder than normal. Symptoms of the disorder include short breath, weakness, fatigue and even heart failure. On Friday, the U.S. Food and Drug Administration (FDA) approved Opsumit, a drug to treat this condition.

The effectiveness and safety of the drug has already been tested in a clinical trial where 742 participants were randomly assigned to take Opsumit or a placebo. The trial, which lasted for two years, proved that the drug was effective in decreasing disease progression. The disease can cause exhaustion and inability to exercise, and the symptoms of PAH worsen requiring additional PAH medication.

Opsumit carries a Boxed Warning, which states that the drug should not be used by pregnant women as it might damage the developing fetus. Moreover, female patients can only receive the drug after enrolling in the Opsumit Risk Evaluation and Mitigation Strategy (REMS) Program. This restricted-distribution program ensures that women comply with applicable pregnancy testing and contraception requirements before initiating treatment. All pharmacies must be certified to distribute Opsumit only to patients who are authorized to receive it.

The medication belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, decreasing blood pressure in the lungs. The side effects include low red blood cell count (anemia), common cold-like symptoms (nasopharyngitis), sore throat, bronchitis, headache, flu and urinary tract infection.

One in every three Americans suffers from hypertension. In certain forms, the disorder is chronic, progressive, debilitating, often leading to death or need for lung transplantation.

Earlier this month, the FDA approved Bayer AG's Adempas, another drug for treating two types of pulmonary hypertension - thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).