Actelion granted EU approval for hypertension treatment

pharmafile | May 17, 2016 | News story | Manufacturing and Production, Sales and Marketing Actelion, Uptravi, eu approval, hypertension 

Actelion Pharmaceuticals has received marketing authorisation from the European Commission for Uptravi (selexipag) for the long-term treatment of patients with pulmonary arterial hypertension (PAH).

PAH is a chronic, life-threatening disorder that is characterised by abnormally high blood pressure in the arteries between the heart and lungs. Although treatment advances have made the condition a long-term one, it remains a progressive disease with high rates of morbidity and mortality. It affects between 6,000-7,000 people in the UK.

Uptravi is a selective IP prostacyclin receptor agonist which works by inducing vasodilation and inhibits proliferation of vascular smooth muscle cells. It has been approved as either a combination therapy in patients insufficiently controlled with related treatments, or as a monotherapy in patients who are not candidates for therapies such as entothelin receptor antagonist (ERA) or phosphodiesterase type 5 inhibitors.

In the Phase III GRIPHON trial, Uptravi demonstrated long-term safety and efficacy. 1,156 patients were enrolled for up to 4.2 years, and treated with Uptravi. The reduction in the time to the first morbidity or mortality event was 40%, compared to 16% on placebo.

Robin Bhattacherjee, general manager at Actelion, comments: “Today’s announcement is a significant milestone in the treatment of PAH. Brining Uptravi to market, where currently the only licensed options are a 24-hour IV infusion or inhalation therapy, is a genuine advancement in the long-term treatment options for patients with PAH. We now hope to secure reimbursement, making Uptravi available to patients in the UK and Ireland.”

Professor Sean Gaine, consultant respiratory physician at the Mater Hospital in Dublin, adds: “With this approach we not only aim to delay disease progression but we are looking for long-term benefits for our patients. Uptravi is a treatment option that could really change the way we treat PAH patients.”

Sean Murray

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