Bayer HealthCare said Tuesday its drug Adempas has been approved as a treatment for two types of pulmonary hypertension, or high blood pressure in the arteries of the lungs.
Bayer said it is already launching the drug, and called Adempas the first drug approved by the Food and Drug Administration as a treatment for more than one type of the disease.
The FDA approved Adempas for use in patients with chronic thromboembolic pulmonary hypertension, or high blood pressure caused by clots and blockages, in patients who have already had surgical treatment and patients who can’t have surgery. The second approval covers pulmonary arterial hypertension, or elevated blood pressure in the pulmonary arteries.
In clinical trials the most common side effects of Adempas were headache, dizziness, indigestion, swelling of the lower limbs, nausea, diarrhea, and vomiting. The drug can harm fetuses, so women will have access to the drug under a program designed to reduce its risks. Physicians are advised not to prescribe the drug to pregnant women.
Bayer HealthCare is a unit of German drugmaker Bayer AG. U.S.-traded shares of Bayer AG slipped 9 cents to $113.98 in morning trading.