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Actelion claims first approval for PAH therapy Uptravi

Gains US approval from the FDA for its key pipeline drug


Swiss biopharma company Actelion chalked up the first approval for a key pipeline drug after the FDA gave the go-ahead for Uptravi, a new therapy for pulmonary arterial hypertension (PAH).

The US regulator approved Uptravi (selexipag) as an orphan drug for PAH, 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.

The new drug is an orally-active prostacyclin receptor agonist that dilates the blood vessels and lowers the pressure in the vessels supplying the lungs. It has been approved to delay disease progression and reduce the risk of hospitalisation in PAH and will be launched early next year, said Actelion.

Uptravi was one of two pipeline projects highlighted by Actelion as being the key to its future growth back in 2012, when it announced a restructuring prompted by increasing competition to its older PAH therapies including Tracleer (bosentan), which is approaching the loss of patent protection in the US.

Since then, approval and launch of the other candidate - Tracleer follow-up Opsumit (macitentan) - has set the company back on track with sales of CHF 354m ($358m) in the first nine months of the year.

Uptravi will compete in the US marketplace with another oral prostacyclin agonist - United Therapeutics' Orenitram (treprostinil) - and Actelion is banking that the data behind its new drug will allow it to quickly supersede its rival. 

Sales of Orenitram were $81m in the first nine months of the year, almost four times the amount booked in the same period in 2014. However, it was approved on the basis of trials using a six-minute walk test endpoint, while the GRIPHON trial of Uptravi showed benefits on both morbidity and mortality.

Actelion's chief executive Jean-Paul Clozel said the new drug will slot into PAH therapy after first-line therapies such as Tracleer, and ahead of drugs used in advanced-stage PAH such as its intravenous Veletri (epoprostenol) product.

Growth prospects for Uptravi and Tracleer have resulted in the Swiss company being linked to a number of potential suitors, including most recently Shire which is in the throes of a takeover attempt on Baxalta.

It was also in discussions about a merger with ZS Pharma, before the latter opted instead for a $2.7bn takeover by AstraZeneca (AZ).

Article by
Phil Taylor

24th December 2015

From: Regulatory



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