Bayer’s riociguat tablets have been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with two types of pulmonary hypertension.
Riociguat is intended for treatment of adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity, as well as with pulmonary arterial hypertension (PAH) to improve exercise capacity.
The company said that riociguat tablets are the first of a novel class of drugs, the soluble guanylate cyclase (sGC) stimulators.
The European Commission’s final decision on the approval is expected in the first half of 2014.
Bayer HealthCare member of the Executive Committee and head of global development Kemal Malik said the company seeks to bring riociguat to patients with these rare, serious and life-threatening diseases upon approval of the European Commission.
“Riociguat is the first drug to demonstrate efficacy in two forms of pulmonary hypertension, PAH and CTEPH,” Malik said.
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“For CTEPH, pulmonary endarterectomy is the primary and potentially curative treatment option. There is no drug treatment approved to date in the European Union. However, a considerable number of CTEPH patients are not operable, and in up to 35% of operated patients the disease persists or reoccurs.”
The recommendation is based on results secured from two randomised, double-blind, placebo-controlled, global Phase III trials CHEST-1 and PATENT-1 and interim results of the long-term extension studies 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.
Both CTEPH and PAH are characterised by significantly increased pressure in the pulmonary arteries.
The primary endpoint, which is a change in exercise capacity, has been met in both the Phase III trials with riociguat after 16 and 12 weeks respectively.
In the trials, the drug also showed consistent improvements across multiple, relevant secondary endpoints, and was generally well-tolerated, with a good safety profile.
The company said that the Phase III trial programmes CHEST and PATENT are ongoing with the long-term extension studies, CHEST-2 and PATENT-2, showing a solid safety profile and sustained efficacy over one year in first interim analyses.
The most commonly reported adverse reactions, occurring in greater than or equal to 10% of patients under riociguat treatment (up to 2.5mg TID), were headache, dizziness, dyspepsia, peripheral edema, nausea, diarrhoea, and vomiting.
In the US, Riociguat was approved under the name Adempas in October 2013 for use in CTEPH and PAH, and in Canada and Switzerland in the CTEPH indication in September and November 2013, as well as in Japan in CTEPH in January 2014.
Bayer HealthCare had filed riociguat for regulatory approval in the EU in both indications in February 2013.
Image: Micrograph showing a plexiform lesion of the lung, as seen in irreversible pulmonary hypertension. Photo: courtesy of Patho.