Opsumit approved for pulmonary arterial hypertension

(HealthDay)—Opsumit (macitentan) has been approved by the U.S. Food and Drug Administration to treat adults with pulmonary arterial hypertension, a debilitating disease characterized by high blood pressure in the lung arteries.

Pulmonary hypertension causes the heart to overwork, which can limit exercise, cause shortness of breath and create the need for a lung transplant. Opsumit relaxes the lung arteries, decreasing in the vessels, the FDA said in a news release.

The drug's safety and effectiveness were evaluated in clinical studies involving 742 people. The medication was found effective in "delaying disease progression," the agency said.

The most common side effects included anemia, cold-like symptoms, bronchitis, headache, flu and urinary tract infection.

Opsumit's label includes a boxed warning that the medication could harm a developing fetus, so the drug should not be taken by pregnant women, the FDA said.

The drug is marketed by Actelion Pharmaceuticals US, based in San Francisco.

More information: To learn more about PAH, visit the U.S. National Heart, Lung and Blood Institute.

add to favorites email to friend print save as pdf

Related Stories

Adempas approved to treat pulmonary hypertension

Oct 09, 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.

Pomalyst approved for advanced multiple myeloma

Feb 09, 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

Aug 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.

Vibativ approved for certain bacterial pneumonia

Jun 24, 2013

(HealthDay)—The antibiotic Vibativ (telavancin) has been approved by the U.S. Food and Drug Administration to treat pneumonia caused by Staphylococcus aureus bacteria when other treatments aren't suitable.

Recommended for you

Boxed warnings are common in novel therapeutics

Aug 19, 2014

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

Aug 19, 2014

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

User comments