Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Adempas, 0.5 mg, 1 mg, 1.5 mg, 2.0 mg and 2.5 mg, film-coated tablets intended for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension.
The active substance of Adempas is Riociguat, an antihypertensive for pulmonary arterial hypertension. Riociguat is a stimulator of soluble guanylate cyclase ( sGC ), an enzyme in the cardiopulmonary system and the receptor for nitric oxide ( NO ). When NO binds to sGC, the enzyme catalyses synthesis of the signalling molecule cyclic guanosine monophosphate ( cGMP ). Intra-cellular cGMP plays an important role in regulating processes that influence vascular tone, proliferation, fibrosis, and inflammation. Riociguat sensitises sGC to endogenous NO by stabilising the NO-sGC binding and directly stimulates sGC independently of NO.
The benefits with Adempas are its ability to provide significant improvement in exercise capacity and pulmonary haemodynamics in CTEPH and PAH.
The most common side effects are headaches, hypotension, gastrointestinal adverse events, dizziness and peripheral oedema. Some reported adverse reactions are of concern considering the reported imbalance with the placebo group, e.g. haemoptysis, pulmonary haemorrhages and renal impairment.
A pharmacovigilance plan for Adempas has been implemented as part of the marketing authorisation.
The approved indication is:
a) chronic thromboembolic pulmonary hypertension ( CTEPH ) - Adempas is indicated for the treatment of adult patients with WHO functional class II to III with inoperable CTEPH, persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity;
b) pulmonary arterial hypertension ( PAH ) - Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension ( PAH ) with WHO functional class ( FC ) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.
Adempas should only be prescribed by physicians experienced in the treatment of CTEPH or PAH. ( Xagena )
Source: EMA ( European Medicines Agency ), 2014
XagenaMedicine_2014
