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FDA approves Adempas to treat pulmonary hypertension
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The FDA announced approval of riociguat for the treatment of adults with two forms of pulmonary hypertension.
Riociguat tablets (Adempas, Bayer HealthCare) are now approved for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgery or adults with inoperable CTEPH who cannot undergo surgery to improve their exercise capacity and WHO functional class. The drug is also indicated for patients with pulmonary arterial hypertension (PAH) of unknown causes, inherited or associated with connective tissue diseases, to improve exercise capacity and delay clinical worsening, according to a press release.
“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,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal drug products in the FDA’s Center for Drug Evaluation and Research, stated in an agency release.
The FDA reviewed Adempas under the priority review program, which provides for an expedited 6-month review of drugs that may offer major advances in treatment.
The safety and effectiveness of the drug to treat CTEPH were established in a clinical trial with 261 participants randomly assigned Adempas up to 2.5 mg three times daily or placebo three times daily. After 16 weeks, the average improvement in 6-minute walk distance was 46 meters more for patients assigned Adempas vs. placebo. A clinical trial evaluating the safety and efficacy of riociguat to treat PAH included 443 patients randomly assigned Adempas 1.5 mg, 2.5 mg or placebo three times daily. After 12 weeks, the average improvement in 6-minute walk distance was 36 meters more for patients assigned Adempas vs. placebo, according to information in the release.
Adempas carries a Boxed Warning to alert patients and health care professionals that it 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 receive counseling on the need for contraception. The REMS restricted distribution program requires prescribers to be certified by enrolling in the program. Also, pharmacies must be certified and can dispense Adempas only to patients who are eligible to receive it under the REMS, according to the release.
Adempas is a stimulator of soluble guanylate cyclase. The most common adverse events associated with the drug include headache, dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux disease and constipation.
“The approval of Adempas equips physicians with a new approach to treating PAH patients, and it gives us the first approved drug treatment for patients with inoperable CTEPH or with persistent/recurrent CTEPH after surgery. While surgery should always be considered as the first treatment option for CTEPH, the fact remains that up to 40% of CTEPH patients are not eligible for surgery, and 10% to 35% of CTEPH patients have disease that persists after surgery,” Nick H. Kim, associate clinical professor of medicine, division of pulmonary and critical care medicine; director of pulmonary vascular medicine; director of the fellowship program at University of California, San Diego, stated in a company release.