FDA OKs riociguat for pulmonary hypertension

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The FDA has approved riociguat for adults with two forms of pulmonary hypertension under its priority review program.

Riociguat (Adempas), a soluble guanylate cyclase stimulator, is indicated for patients with chronic thromboembolic pulmonary hypertension after surgery or patients who cannot undergo surgery to improve their ability to exercise; and in patients with pulmonary arterial hypertension to improve their ability to exercise and to delay clinical worsening of their condition.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee panel voted unanimously for its approval in August.

Riociguat should not be prescribed to pregnant women because it can harm the developing fetus, according to its Boxed Warning. The drug is available to women only through a restricted program, the Adempas Risk Evaluation and Mitigation Strategy Program. It also is contraindicated for co-administration with nitrates or nitric oxide donors in any form and concomitant administration with phosphodiesterase inhibitors.

Wayne, N.J.-based Bayer HealthCare Pharmaceuticals markets the drug.