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Actelion gets EU go-ahead for Uptravi in PAH

Oral therapy predicted to become $1bn-plus product

Actelion's therapy for pulmonary artery hypertension (PAH) Uptravi has been approved in the EU, five months after getting a green light in the US.

The Swiss biopharma company rates Uptravi (selexipag) as one of the most important drugs in its pipeline as it deals with competition to older products in its PAH franchise such as Tracleer (bosentan).

The orally-active, first-in-class IP prostacyclin receptor agonist has been predicted to become a $1bn-plus product for Actelion, helped by a high price tag that in the US runs at around $160,000-$170,000 per year.

Uptravi has been approved by the European Medicines Agency (EMA) for the long-term treatment of PAH in adult patients with WHO functional class II-III - in other words patients who have slight to marked limitations in physical activity but who are generally comfortable at rest.

It can be used either as a combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in those unable to take these therapies.

PAH is high blood pressure that occurs in the arteries that connect the heart to the lungs and can cause serious complications including heart failure and arrhythmia.

While there are a number of drug classes available to treat PAH - including ERAs, PDE-5 inhibitors and intravenous and inhaled prostacyclin agonists - the disease is still highly life-threatening with a five-year survival rate of less than 40%.

Uptravi's approval comes on the back of the phase III GRIPHON study, which showed that PAH complications or death were reduced by 40% with Uptravi compared to placebo, with the benefits mainly coming from reductions in hospitalisations and disease progression.

Prostacyclin agonists have demonstrated benefits in PAH but as a class have been underused - with typically only around one in five PAH patients receiving them at any time during their therapy, according to Professor Sean Gaine, consultant respiratory physician at Mater Misericordiae Hospital in Dublin, Ireland.

"Uptravi, as an innovative oral treatment that is supported by long-term outcome results, now allows us to offer combination therapy regimens that target all three established treatment pathways," he said.

According to market research firm GlobalData, the PAH market will expand gradually from $3.45bn in seven top markets (the US, Japan, Germany, France, the UK, Italy and Spain) in 2014 to $4.75bn by 2024, driven by new drug launches.

Among these, Uptravi is predicted to be the biggest-seller with sales of $996m by 2024, it says, adding that rival oral prostacyclin therapy beraprost sodium 314d from Lung Biotechnology - currently in phase III trials - "does not demonstrate as much potential due to its lack of clinical superiority over other existing prostacyclin-based therapies".

Article by
Phil Taylor

18th May 2016

From: Regulatory



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