Magazine article Drug Topics

FDA Approves Riociguat for PAH

Magazine article Drug Topics

FDA Approves Riociguat for PAH

Article excerpt

NEW TREATMENT

FDA has approved riodguat (Adempas, Bayer Healthcare Pharmaceuticals) tablets to treat adults with chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment, adults with inoperable CTEPH, and adults with pulmonary arterial hypertension (PAH).

Riociguat is "a new treatment option for patients with PAH and CTEPH, two life-threatening forms of pulmonary hypertension," said Pamela A. Cyrus, MD, vice president and head, U.S. medical, Bayer Healthcare Pharmaceuticals. "Adempas is now the only treatment approved in the United States for use in two types of pulmonary hypertension [WHO Groups 1 and 4]. It is the only FDA-approved drug therapy for persistent/ recurrent CTEPH after surgical treatment or inoperable CTEPH. The standard treatment for CTEPH is and should remain pulmonary endarterectomy. However, 20% to 40% of patients have inoperable CTEPH, and the disease persists in up to 35% of those who do undergo surgery."

Action

Riodguat, a stimulator of soluble guanylate cydase (sGC), represents a new drug dass. Its novel mode of action may overcome several limitations affecting other approved PAH therapies, induding nitric oxide (NO) dependence. …

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