Among the fives types of PH, Pulmonary Arterial Hypertension (PAH) is recognized as a serious unmet medical need in terms of viable treatments, due to the progressive and life-threatening characteristics of the disease. PAH patients experience symptoms where blood pressure in the pulmonary arteries is significantly heightened due to vasoconstriction, frequently leading to low quality of life and shortened lifespan. Bayer’s Adempas, however, which has been approved by the FDA for the treatment of both PAH and chronic thromboembolic pulmonary hypertension (CTEPH), does offer medical practitioners a viable option for treatment. Now, according to a recent press release, the European Commission has followed suit, approving Adempas, which is also known as its generic name riociguat, for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension in Europe.
Adempas, which is part of a novel class of compounds, is a soluble guanylate cyclase (sGC) stimulator, and the first and only therapy that has been approved to treat CTEPH. With this new EU approval, the drug will now be used in Europe as a treatment option for adult patients with inoperable CTEPH or persistent or recurrent CTEPH after surgical treatment. Adempas is also approved for use in treating adult patients with pulmonary arterial hypertension, either as a mono therapy (not combined with any other drug) or as part of a combination therapy that includes endothelia receptor antagonists.
According to Bayer, the decision on the part of the EU commission came as a result of positive data published from two randomized, double-blind, placebo-controlled, global Phase III studies known as CHEST-1 and PATENT-1, in addition to long-term studies CHEST-2 and PATENT-2, all of which were designed to test the drug’s safety and effectiveness in patients with both PAH and CTEPH, speficially in administering the oral version of riociguat in the treatment of the diseases.
For adults with these PH types in Europe, the news of the Adempas approval will hep to expand treatment options for the disease, particularly with respect to CTEPH and PAH.