Bayer Inc. announced today that the Health Canada has approved the drug Adempas (riociguat) for the treatment of inoperable, or persistent and recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgery in adult patients with World Health Organization Functional Class I or II pulmonary hypertension.
CTEPH is an uncommon form of pulmonary hypertension (PH), a severe, progressive and life-threatening condition of the heart and lungs that affects up to several thousand people in Canada. Patients with PH develop high blood pressure in the arteries of the lungs, which causes breathlessness and fatigue, hindering their ability to work and carry out everyday activities, like walking – even a short distance – in some cases.
“Before today, we had no proven drug treatments for patients with inoperable CTEPH or patients in whom surgery was not successful in curing their CTEPH. Adempas gives us an effective drug treatment with proven clinical efficacy and good tolerability,” said Dr. John Granton, head of the Division of Respirology University Health Network, Mount Sinai Hospital, and Women’s College Hospital. He added that, because of the complex nature of PH, “Patients should be referred to an expert PH centre as soon as possible for a thorough assessment and timely treatment.”
Results from a major clinical trial showed that riociguat is the first ever drug to provide statistically significant clinical improvement in patients with inoperable CTEPH or persistent/recurrent PH disease at the end of 16 weeks of treatment. Improvements were seen in a range of disease-related measures such as reduction in patients’ resistance to blood flow in the arteries of the lungs, and in markers of disease severity. Riociguat also significantly improved their exercise capacity measured by a six-minute walk test (6MWT).
“Riociguat will be welcomed by patients with CTEPH who, up to now, have not had a proven drug treatment option available to them if their disease is inoperable or for those experiencing residual PH following surgery. CTEPH is a devastating diagnosis, and the symptoms of breathlessness, dizziness and fainting can be frightening and have a severe impact on daily activities. To have a treatment that achieves meaningful clinical improvements is a much needed step forward,” said Frank Poon, president of the Pulmonary Hypertension Association of Canada.
The standard and potentially curative treatment option for patients who have developed CTEPH is a surgical procedure called pulmonary endarterectomy that mechanically clears the blood vessels of the lungs of scar tissue caused by the disease. However, the disease persists or recurs after surgery in up to 35% of patients. Many patients (20%-50%) with CTEPH are not candidates for surgery and, like patients with residual PH, urgently need effective new treatments to manage their disease.
Long-term trials of the riociguat study program in CTEPH are ongoing, and first results show that safety and tolerability as well as efficacy (change in 6MWT) are sustained over one year.
Date: September 23, 2013
Source: Bayer Inc.