European Commission Approves Bayer's Adempas For Hypertension
Bayer reported that it has received approval from the European Commission for Adempas (riociguat) for the treatment of patients with chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) in the EU.
Adempas is the first and currently the only approved treatment for patients with CTEPH. The drug is indicated for the treatment of adult patients with inoperable CTEPH or persistent or recurrent CTEPH after surgical treatment. The drug is also indicated for the treatment of adult patients with PAH as a monotherapy or combined with endothelin receptor antagonists.
Dr. Jörg Möller, member of the Bayer HealthCare Executive Committee and head of Global Development, said, “With the approval of Adempas by the European Commission, an important new treatment option becomes available for patients with pulmonary hypertension in Europe. Adempas is the first drug that has shown benefits across multiple clinically-relevant endpoints in two pulmonary hypertension indications, namely CTEPH and PAH. For the first time, there is a pharmacological treatment option for patients with CTEPH who are not eligible for surgery or whose disease persists or reoccurs.”
Pulmonary arterial hypertension is one of the five types of pulmonary hypertension. It is a progressive and life-threatening disease in which vasoconstriction increases pressure in the pulmonary arteries and can lead to heart failure and death. Chronic thromboembolic pulmonary hypertension is also a type of pulmonary hypertension which can result in an overload of the right heart. It is thought that thromboembolic occlusion plays a part in CTEPH by gradually increasing blood pressure in the pulmonary arteries.
Riociguat, a soluble uanylate cyclase (sGC) stimulator, is the first member of a new class of compounds. The drug was discovered by Bayer and being developed as an oral treatment to target a key molecular mechanism underlying pulmonary hypertension.
“With riociguat we have for the first time an effective drug treatment for two forms of PH. Under treatment with riociguat, the patient’s quality of life is rapidly improving, which is noticeable to them and clearly visible to us,” said Professor Ardeschir Ghofrani, University Hospital Giessen and Marburg, Germany, principal investigator in the pivotal Phase 3 trials CHEST and PATENT.
The company said that the approval of Adempas jumpstarts the global perspective exposure registry EXPERT, which will gather data on the safety and clinical efficacy of the first-in-class sGC-stimulator in real-life clinical practice.