Johnson & Johnson-owned Janssen Pharmaceuticals has submitted an application to the FDA for approval of what would be the first tablet therapy for patients with pulmonary arterial hypertension.
The drugmaker's move to seek FDA approval comes after positive results from a phase 3 trial, which found the therapy was able to demonstrate significant improvement in patients' conditions, according to a May 30 news release.
While rare, pulmonary arterial hypertension is a serious condition that causes high blood pressure in the arteries of the lungs. In clinical trials, the tablet, known as Opsumit, lowered patients' risk of hospitalization due to the condition and slowed the progression of the disease.
Should the FDA grant approval of the drug, it "has the potential to cover all guidelines and recommended treatment pathways," the release states.