August 7th, 2013
FDA Panel Recommends Approval of New Pulmonary Hypertension Drug
The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two forms of pulmonary hypertension: pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTPH).
Bayer proposed an initial dose of 1 mg three times daily and a maximum dose of 2.5 mg three times daily. Due to concerns about hypotension, FDA reviewers initially recommended that the drug not be approved at the 2.5-mg dose and instead recommended a starting dose of 0.5 mg. Ultimately, the panel decided to grant as many options as possible to physicians and recommended a starting dose of 0.5 mg and a maximum dose of 2.5 mg.
The panel meeting was largely devoted to two clinical trials, CHEST-1 and PATENT-1, whose findings were recently published in the New England Journal of Medicine. Both trials showed that patients taking riociguat had a modest improvement in their ability to walk.
CardioExchange’s John Ryan, an expert on pulmonary hypertension, sent the following comment:
The issue will be where PAH specialists feel this agent fits in their therapeutic options. It remains to be seen whether riociguat will become first line therapy and replace oral medicines that PAH doctors are familiar with, namely PDE5 Inhibitors and endothelin receptor antagonists, or if it will be additive on top of these agents. In PATENT-1, 50% of the patients were not taking other agents, so how they interact with each other is largely unknown.