FDA Approves Adempas (Riociguat) for Pulmonary Hypertension
Treatment improves exercise capacity in phase III trials (October 9)
The FDA has approved Adempas (riociguat, Bayer Healthcare) tablets for use in two forms of pulmonary hypertension. The drug is approved for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and World Health Organization (WHO) functional class; and for the treatment of adults with pulmonary arterial hypertension (PAH) to improve exercise capacity, to improve WHO functional class, and to delay clinical worsening.
Adempas (riociquat) is the only treatment approved in the U.S. for use in two types of pulmonary hypertension and is the only FDA-approved drug therapy for CTEPH that is inoperable or persistent/recurrent after surgical treatment.
The FDA’s approval was based on data from two randomized, double-blind, placebo-controlled, phase III studies (CHEST-1 and PATENT-1) as well as on long-term data from two other trials (CHEST-2 and PATENT-2) available at the time. These studies investigated the efficacy and safety of oral riociguat in the treatment of CTEPH and PAH, respectively.
Both phase III studies (CHEST-1 and PATENT-1) met their primary endpoint, a change in exercise capacity, after 16 and 12 weeks, respectively. In these trials, patients demonstrated a statistically significant improvement in exercise capacity, as measured by the 6-minute walk test. Riociquat also demonstrated consistent improvements across multiple secondary endpoints.
Source: PipelineReview; October 9, 2013.