FDA approved the 2nd New Agent for the Treatment of Pulmonary Hypertension

Pulmonary hypertension is chronic debilitating disease associated with high morbidity and a poor prognosis.

After approval of riociguat (Adempas, Bayer), for the treatment of PAH and the treatment of chronic thromboembolic pulmonary hypertension (CTEPH), on October 8.

The US Food and Drug Administration (FDA) have approved the second agent this month to treat pulmonary arterial hypertension (PAH) in adults which is macitentan (Opsumit, Actelion).

Novel oral vasodilator approved to treat pulmonary hypertension

Riociguat, a potent vasodilator that is the first in a new class of drugs, has been approved by the Food and Drug Administration for treating two types of pulmonary hypertension in adults.

The drug, which will be marketed as Adempas, was approved Oct. 8 to treat:

1-chronic thromboembolic pulmonary hypertension (CTEPH) and,

2- pulmonary arterial hypertension (PAH),.

Orally administered in tablet form, riociguat is a soluble guanylate cyclase (sGC) stimulator, the first drug in this class to be approved for pulmonary hypertension. It is also "the first drug of any class to be shown to be effective for patients with CTEPH

Riociguat is a pregnancy category X drug and is available to women only through a Risk Evaluation and Mitigation Strategy (REMS) program.

The approved indications for the drug, which will be marketed by Bayer HealthCare Pharmaceuticals, are for:

1-persistent/recurrent CTEPH (WHO group 4) "after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class" or PAH (WHO group 1) "to improve exercise capacity, improve WHO functional class, and to delay clinical worsening."

Approval was based on the results of two international studies that found treatment resulted in significant improvements over placebo in the 6 minute walk test.