Bayer’s Adempas® (riociguat), the first and only drug available in the UK to treat patients with chronic thromboembolic pulmonary hypertension (CTEPH), who cannot have surgery, approved by European Medicines Agency (EMA)
Adempas® (riociguat) is available in the UK today as the first drug treatment for CTEPH, to treat adult patients with WHO Functional Class (FC) II to III with inoperable or persistent disease to improve exercise capacity. CTEPH, which affects close to 1,300 people in the UK, is a rare form of Pulmonary Hypertension (PH), a severe, progressive and life-threatening condition of the heart and lungs. Patients develop high blood pressure in the pulmonary arteries, which causes breathlessness, fatigue and hinders their ability to work and carry out everyday activities.
The standard and potentially curative treatment for CTEPH is pulmonary endarterectomy (PEA), a surgical procedure in which the blood vessels of the lungs are cleared of the clot and scar material caused by the disease.9 But many patients (20%-40%) with CTEPH are inoperable. These patients urgently need effective new treatments to manage their disease.
“This new drug is the only proven medical therapy to improve symptoms in patients with inoperable CTEPH. As a surgeon, I should emphasise that pulmonary endarterectomy surgery remains the first choice therapy to cure this condition, and all patients in the UK who have susptected CTEPH should be referred to their regional designated pulmonary hypertension expert centre for assessment. There are a significant minority number of patients who are unable to undergo surgery that might benefit from riociguat and it is reassuring to have another treatment option to help them.” David Jenkins, Consultant Cardiothoracic Surgeon, Director National Pulmonary Endarterectomy Service.
“Until today there were no other treatment options, aside from surgery, for those diagnosed with this disease. CTEPH can have a devastating impact on the lives of patients who, on a daily basis, struggle to breathe and experience dizziness and fainting, all which can be very frightening. As such riociguat is the start of a new era in the management of CTEPH.” Iain Armstrong, Consultant Nurse, Royal Hallamshire Hospital.
Riociguat is a soluble guanylate cyclase (sGC) stimulator, the first member of a new class of compounds discovered by Bayer HealthCare. With its new mode of action, riociguat has been developed as an oral treatment to target a key molecular mechanism underlying this serious disease.
Prof. Johannes-Peter Stasch, Chief Scientist at Bayer and lead in the discovery of Riociguat and sGC stimulators, commented: “The availability of riociguat is a landmark in our mission to bring this urgently needed treatment to patients living with CTEPH or PAH. We are proud to have led the way in this disease area and to be the first company to have succeeded in bringing a proven CTEPH treatment from the laboratory bench to the patient bedside.”
Results from a pivotal phase III trial, CHEST-1, showed that riociguat is the first ever drug to provide statistically significant clinical efficacy in patients with inoperable CTEPH or recurrent or persistent disease after surgery. Riociguat significantly improved patients’ exercise capacity, measured using the six-minute walk test (6MWT), a marker of disease progression and mortality. In CHEST-1, patients receiving riociguat were able to walk an average of 46 additional metres (95%-CI [25-67 meters] p<0.0001) in the 6MWT from baseline after 16 weeks compared with placebo. There were also significant improvements in other markers of disease severity including patients’ cardiopulmonary haemodynamics, WHO Functional Class and disease-related biomarkers.
Riociguat is also indicated to treat patients with PAH, another type of PH in which the prognosis for patients remains poor despite the availability of several approved PAH therapies. Riociguat demonstrated statistically significant improvement in exercise capacity in treatment-naïve PAH patients as well as in patients pre-treated with an endothelin receptor antagonist or prostanoid monotherapy, in the PATENT-1 pivotal Phase III trial. PATENT-1 patients treated with riociguat were able to walk an average of 36 additional metres (95%-CI [20-52 meters] p<0.0001) from baseline compared with placebo in the 6MWT. Riociguat also met a range of other markers of disease severity, including cardiopulmonary haemodynamics, WHO functional class, disease-related biomarkers and time to clinical worsening.
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