EU CHMP recommends approval of Uptravi (selexipag) for pulmonary arterial hypertension- Actelion

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uptravi (selexipag), from Actelion, intended for the treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III. Uptravi was designated as an orphan medicinal product on 26 August 2005. Uptravi will be available as 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg and 1,600 mcg film-coated tablets.

The benefits with Uptravi in patients with PAH are its ability to dilate the pulmonary arteries as well as its anti-proliferative and anti-fibrotic effects, which decrease pulmonary arterial pressure and delay disease progression. The most common side effects are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia, pain in extremity, arthralgia and flushing. The majority of these reactions are of mild to moderate intensity.