Oct. 8 (Bloomberg) -- Bayer AG’s lung drug won U.S. approval to treat two forms of pulmonary hypertension.
The Food and Drug Administration said it cleared the drug, known chemically as riociguat. Pulmonary hypertension can lead to death or the need for a lung transplant, the agency said today in a statement approving the drug.
The pill, Adempas, is the first to treat the form of the condition that lasts six months or longer often caused by a blood clot in the lungs called chronic thromboembolic pulmonary hypertension, or CTEPH. The treatment from Leverkusen, Germany-based Bayer may generate sales of $639 million in 2017, according to the average of six analysts’ estimates compiled by Bloomberg.
“Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH,” Norman Stockbridge, director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.
The World Health Organization separates pulmonary hypertension, or high blood pressure in the arteries to the lungs that makes the heart work harder, into five categories.
The FDA approved Adempas to help CTEPH patients improve their ability to exercise. The condition affects about 5,000 people each year and now is treated with a complex surgery, according to the Cleveland Clinic. Adempas can be used after surgery or by those who can’t undergo surgery, the FDA said.
The drug also is approved to treat pulmonary arterial hypertension that is often inherited or has no known cause to improve patients’ ability to exercise and delay worsening of the condition.
“Adempas belongs to a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure,” the FDA said.
Actelion Ltd., based in Allschwil, Switzerland, is seeking FDA approval for macitentan to treat pulmonary arterial hypertension. The agency is expected to decide by Oct. 19.
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