FDA Advisory Committee Recommends Approval of Pulmonary Hypertension Drug
The U.S. Food and Drug Administration (FDA) should approve riociguat for the treatment of both pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), according to an FDA advisory panel. After a day of discussions, the Cardiovascular and Renal Drugs Advisory Committee on Aug. 6 voted 11-0 in favor of approval. However, the committee did not agree with FDA reviewers who recommended reducing the drug’s dose if approved due to potential risk of hypotension at higher doses.
In clinical trials, riociguat improved the distance patients could walk during a six-minute test. The PATENT-1 trial examined riociguat in PAH and the CHEST-1 trial looked at riociguat in patients with CTEPH.
If approved, the drug would be the first on the market to treat pulmonary hypertension that lasts for six months or more. Riociguat (proposed brand name Adempas), a soluble guanylate cyclase (sGC) stimulator manufactured by Bayer, would join phosphodiesterase type 5 inhibitors, prostanoids and endothelin-receptor antagonists that are already on the market for the treatment of PAH.
While the FDA is not required to follow the advisory committee’s recommendation, it’s a significant factor in the Agency’s decision-making.
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