FDA approves Adempas for pulmonary hypertension
FDA Approves Adempas to Treat Pulmonary Hypertension
HealthDay News -- The FDA has approved riociguat (Adempas, Bayer) to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) of various causes.
The drug is among a class of drugs called soluble guanylate cyclase stimulators, which relax the arteries to increase blood flow and decrease BP, the agency said. It has been approved for people with CTEPH who either not responded to pulmonary endarterectomy or who cannot have surgery to help improve the ability to exercise.
The drug also was approved for people with PAH of unknown causes, inherited or associated with connective tissue diseases, to improve their ability to exercise and to delay clinical worsening of their condition.
Riociguat was evaluated in a clinical study involving 261 people with CTEPH. People who were treated with the drug were able to walk about 150 feet further in six minutes after 16 weeks of treatment than people who took a placebo, the FDA said.
In another trial of 443 people with PAH, those treated with the drug were able to walk about 118 feet further in six minutes after 12 weeks of treatment than those who had been treated with a placebo.
In both trials, riociguat also improved some secondary endpoints, including systemic vascular resistance and World Health Organization functional class.
The most common side effects of the drug included headache, dizziness, dyspepsia, peripheral edema, nausea and vomiting.
The label for riociguat will also include a boxed warning that pregnant women shouldn't use the drug because of the risk of adverse effects on the fetus. Female, but not male, patients will be required to enroll in a Risk Evaluation and Mitigation Strategy (REMS) program in order to receive the drug.
"All female patients must be enrolled in the program, comply with pregnancy testing requirements, and be counseled regarding the need for contraception," according to the FDA.
All prescribers are also required to enroll in the REMS program, and only certified pharmacies will be able to carry the medication.
Additional contraindications for riociguat use include use at the same time as nitrates, nitric oxide donor drugs and PDE inhibitors, including specific PDE5 inhibitors and nonspecific PDE inhibitors.