Bloomberg News (10/9, Edney, 1.91M) reports that the Food and Drug Administration announced that it has granted approval to Bayer AG’s pulmonary hypertension drug riociguat (Adempas) for the treatment of two forms of the condition. The medication “is the first to treat the form of the condition that lasts six months or longer often caused by...chronic thromboembolic pulmonary hypertension.” The FDA said the drug is from “a class of drugs called soluble guanylate cyclase stimulators that help arteries relax to increase blood flow and decrease blood pressure.”
Reuters (10/9, Clarke) adds that the drug will include a boxed warning advising against its use in pregnant women because of the potential for fetal harm.
Forbes (10/8, 6.03M) contributor Larry Husten writes that Director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research, Norman Stockbridge, said in a press release, “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.” Medscape (10/9, Wood, 164K) also reports on the story.
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