Adempas approved to treat pulmonary hypertension

October 9, 2013

(HealthDay)—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 , the agency said.

The drug was approved for people with chronic thromboembolic (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 (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 said.

The is marketed by Wayne, N.J.-based Bayer HealthCare Pharmaceuticals.

More information: The FDA has more about this approval.

Related Stories

Iclusig approved for rare leukemias

December 16, 2012

(HealthDay)—Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia..

Pomalyst approved for advanced multiple myeloma

February 9, 2013

(HealthDay)—Pomalyst (pomalidomide) has been approved by the U.S. Food and Drug Administration to treat cases of multiple myeloma that have not responded to other therapies.

New drug approved to treat HIV-1

August 13, 2013

(HealthDay)—Tivicay (dolutegravir) has been approved by the U.S. Food and Drug Administration to treat infection with HIV-1, a strain of the virus that causes AIDS.

Brintellix approved for major depressive disorder

October 1, 2013

(HealthDay)—Brintellix (vortioxetine) has been approved by the U.S. Food and Drug Administration to treat adults with major depressive disorder, often referred to as depression.

Recommended for you

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.