-- Scott Roberts
WEDNESDAY, Oct. 9 (HealthDay News) -- Adempas (riociguat) has
been approved by the U.S. Food and Drug Administration to treat two
types of pulmonary hypertension, characterized by high blood
pressure in the arteries of the lungs.
The chronic, disabling disease forces the heart to work harder
than usual, and can lead to death or the need for a lung
transplant, the FDA said in a news release.
Adempas, among a class of drugs called soluble guanylate cyclase
stimulators, relaxes the arteries. This increases blood flow and
eases blood pressure, the agency said.
The drug was approved for people with chronic thromboembolic
pulmonary hypertension (CTEPH) after surgery, or for people who
cannot have surgery, to help improve the ability to exercise. The
drug also was approved for people with pulmonary arterial
hypertension (PAH) of various causes.
Adempas was evaluated in a clinical study involving 261 people
with CTEPH. People who were treated with the drug were able to walk
about 150 feet further in six minutes after 16 weeks of treatment
than people who took a placebo, the FDA said.
In another trial of 443 people with PAH, people treated with the
drug were able to walk about 118 feet further in six minutes than
those who had been treated with a placebo.
The most common side effects of the drug included headache,
dizziness, indigestion, tissue swelling, nausea and vomiting.
Adempas' label includes a boxed warning that pregnant women
shouldn't use the drug, which can harm a growing fetus, the agency
The drug is marketed by Wayne, N.J.-based Bayer HealthCare
The FDA has more about
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