Drugs Xagena
The CHMP ( European Committee for Medicinal Products for Human Use ) has recommended approval for Riociguat tablets for use in two forms of pulmonary hypertension, a group of life-threatening and progressive diseases: the treatment of adult patients with inoperable chronic thromboembolic pulmonary hypertension ( CTEPH ) or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity, and the treatment of adult patients with pulmonary arterial hypertension ( PAH ) to improve exercise capacity.
Riociguat is the first of a novel class of drugs, the soluble guanylate cyclase (sGC)-stimulators. Its new mode of action has been developed to target a key molecular mechanism underlying pulmonary hypertension.
The CHMP recommendation is based on results from the two randomized, double-blind, placebo-controlled, global phase 3 studies CHEST-1 and PATENT-1 as well as on interim results of the long-term extension studies CHEST-2 and PATENT-2 available at the time.
These assessed the efficacy and safety of oral Riociguat in the treatment of CTEPH and PAH respectively. PAH and CTEPH are two rare and life-threatening forms of pulmonary hypertension characterized by significantly increased pressure in the pulmonary arteries.
Both phase 3 studies with Riociguat met their primary endpoint, a change in exercise capacity, after 16 and 12 weeks respectively.
Riociguat has also demonstrated consistent improvements across multiple, relevant secondary endpoints, and was generally well-tolerated, with a good safety profile.
Results of both studies were published in the New England Journal of Medicine ( NEJM ) in July 2013.
The phase 3 trial programs CHEST and PATENT are ongoing with the long-term extension studies, CHEST-2 and PATENT-2, showing in first interim analyses a good safety profile and sustained efficacy over one year.
The most commonly reported adverse reactions, occurring in greater than or equal to 10% of patients under Riociguat treatment ( up to 2.5 mg TID ), were headache, dizziness, dyspepsia, peripheral edema, nausea, diarrhea, and vomiting. ( Xagena )
Source: Bayer HealthCare, 2014
XagenaMedicine_2014
