The European Commission has approved Bayer‘s Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) in the European Union (EU).
The drug is indicated for treatment of adult patients with inoperable CTEPH or persistent or recurrent CTEPH after surgical treatment, as well as to treat adult patients with PAH as a monotherapy or in combination with endothelin receptor antagonists.
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Adempas is a soluble guanylate cyclase (sGC) stimulator, and is the first and only drug treatment approved for patients with CTEPH.
Bayer HealthCare member of the executive committee and head of global development Jörg Möller said with the approval of Adempas by the European Commission, an 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,” Möller said.
“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.”
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By GlobalDataApproval is based on results from the two randomised, double-blind, placebo-controlled, global Phase III trials CHEST-1 and PATENT-1 as well as long-term data from CHEST-2 and PATENT-2 available at the time.
The trials evaluated the efficacy and safety of oral riociguat in the treatment of CTEPH and PAH respectively.
With EU approval, the global prospective Adempas exposure registry EXPERT has been started, which will collect data on safety and clinical effect of this sGC-stimulator in real-life clinical practice.
European Pulmonary Hypertension Assocation member Pisana Ferrari said the availability of riociguat is a significant step forward for people with breathing difficulties.
“The therapy enables patients to take part in everyday activities, which many of us take for granted,” Ferrari said.
“We also welcome the availability of a new class of medicines to help patients suffering from PAH meet their treatment goals.”
The standard and potentially curative treatment for CTEPH is PEA, a surgical procedure where the blood vessels of the lungs are cleared of clot and scar material.
Bayer said that riociguat is the first and only drug to show significant and sustained clinical efficacy in patients with inoperable CTEPH or persistent or recurrent CTEPH after surgical treatment.
The consistency and robustness of the positive results in the Phase III trials showed that riociguat relieved many symptoms experienced by people living with CTEPH or PAH.
Image: Micrograph showing a plexiform lesion of the lung, as seen in irreversible pulmonary hypertension. Photo: courtesy of Patho.
