Bayer Lung Drug Should Be Approved at Low Dose, FDA Says
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Bayer AG’s experimental treatment for two forms of pulmonary hypertension is being recommended for approval by U.S. regulatory staff at a lower dose than what the company sought.
Bayer’s riociguat improved the distance patients can walk during a six-minute test in clinical trials, Food and Drug Administration staff said today in a report ahead of a meeting of agency advisers Aug. 6. The pill would be the first to treat pulmonary hypertension that lasts six months or longer often caused by a blood clot in the lungs.