- FDA approves Plan B One-Step OTC switch
- FDA approves Opsumit for pulmonary arterial hypertension
- Federal government must find alternatives to rescheduling hydrocodone combination drugs
- Senate passes Drug Quality and Security Act
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
SILVER SPRING, Md. — The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.
Adempas is intended for patients with chronic thromboembolic pulmonary hypertension, or CTEPH, after surgery or patients who cannot undergo surgery, to improve their ability to exercise. Adempas is also indicated for patients with pulmonary arterial hypertension, or 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.
“Adempas is the first in its drug class approved to treat pulmonary hypertension and the first drug of any class to be shown to be effective for patients with CTEPH,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research.
Adempas will carry a boxed warning alerting patients and healthcare professionals that the drug should not be used in pregnant women because it can harm the developing fetus. Female patients can receive the drug only through the Adempas REMS program. All female patients must be enrolled in the program, comply with pregnancy testing requirements and be counseled regarding the need for contraception. The REMS restricted distribution program also requires prescribers and pharmacies to be certified by enrolling in the program.