FDA adds Opsumit to approved PAH drug list

Candace Stuart | | Cardiovascular Business | Structural Heart Disease

The FDA approved macitentan as a treatment for adults with pulmonary arterial hypertension (PAH).

Macitentan (Opsumit, Actelion Pharmaceuticals) is an endothelin receptor blocker. It has a boxed warning that explains the drug should not be used in pregnant women because it can harm the fetus. Female patients can receive the drug only through the Opsumit Risk Evaluation and Mitigation Strategy Program.

The FDA assessed its safety and efficacy based on a placebo-controlled randomized clinical trial that enrolled 742 participants with a two-year follow-up. Results showed that macitentan delayed progression of PAH.

Candace Stuart, Contributor

Related Content

CMS proposes Medicare coverage for transcatheter tricuspid valve replacement
Hydra TAVR valve gains key approval as global reach continues to grow
SAVR outperforms TAVR in patients with bicuspid aortic valves
Treating AFib patients with TAVR still linked to elevated risks
Heart surgeons detail world’s first robotic heart procedure of its kind
Years of progress have made TAVR more effective when treating concomitant mitral stenosis

Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.