This article is more than 5 years old. Information may no longer be current.
FDA advisory panel favors approval of riociguat
Click Here to Manage Email Alerts
In August, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 11-0 to recommend approval of riociguat to treat patients with pulmonary arterial hypertension and patients with chronic thromboembolic pulmonary hypertension. Riociguat is a novel stimulator of soluble guanylate synthase.
If riociguat receives FDA approval, the drug will be marketed by Bayer HealthCare under the brand name Adempas.
Bayer sponsored two clinical trials to assess the safety and efficacy of riociguat. Both drew praise from the panel for good design and conduct. PATENT-1 evaluated riociguat in patients with symptomatic PAH. CHEST-1 evaluated riociguat in patients with chronic thromboembolic pulmonary hypertension for whom pulmonary endarterectomy was ineffective or who were ineligible for surgery. In both trials, patients assigned riociguat showed improved 6-minute walk distance compared with patients assigned placebo. Riociguat was also associated with better pulmonary vascular resistance, NT-proBNP levels and Borg dyspnea score.
Much of the committee’s discussion concerned not whether riociguat should be approved, but the appropriate starting and maximum dosages that should be specified.
“My plea to the [FDA] is to let doctors be doctors. We have the ability to determine what the optimal dosage is,” panel member Stuart Rich, MD, cardiologist at the Center for Pulmonary Hypertension at University of Chicago Hospitals, said at the meeting.
The committee ultimately recommended a maximum dosage of 2.5 mg three times a day and a starting dosage of 0.5 mg three times a day.
Prior to the meeting, Bayer and FDA officials agreed that riociguat’s label will have a warning about risk for hemoptysis and that the drug will be contraindicated for concomitant use with nitrates. The panel members recommended that it was not necessary at this time to also contraindicate riociguat in patients with known CAD who may need nitrates in the future.
Bayer issued a statement praising the committee’s decision: “We appreciate the committee’s discussion … around the safe and appropriate use of riociguat and are pleased with the outcome of the votes,” Pamela A. Cyrus, MD, vice president and head of US medical affairs for Bayer HealthCare Pharmaceuticals, stated in the release. “If approved, riociguat will offer a new treatment option for patients with PAH and will also provide the first approved non-surgical treatment option for [chronic thromboembolic pulmonary hypertension] patients who are inoperable or who have recurrent or persistent disease.”
Although the FDA is not required to follow the recommendations of the advisory committee, it usually does.