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.

Explore further: Stivarga approved for advanced colorectal cancer

More information: The FDA has more about this approval.

Related Stories

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.

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..

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

Researchers identify source of opioids' side effects

January 17, 2017

A commercially available drug may help drastically reduce two side effects of opioid painkillers—a growing tolerance and a paradoxical increased sensitivity to pain—without affecting the drugs' ability to reduce pain, ...

CVS generic competitor to EpiPen, sold at a 6th the price

January 12, 2017

CVS is now selling a rival, generic version of Mylan's EpiPen at about a sixth of its price, just months after the maker of the life-saving allergy treatment was eviscerated before Congress because of its soaring cost to ...

Many misuse OTC sleep aids: survey

December 29, 2016

(HealthDay)—People struggling with insomnia often turn to non-prescription sleep remedies that may be habit-forming and are only intended for short-term use, according to a new Consumer Reports survey.

The pill won't kill your sexual desire, researchers say

December 15, 2016

Taking the pill doesn't lower your sexual desire, contrary to popular belief, according to research published in the Journal of Sexual Medicine. The authors of the research, from the University of Kentucky and Indiana University ...

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.