FDA approves Actelion's new drug to treat PAH

The US Food and Drug Administration has approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.

The drug, originated with by Japan's Nippon Shinyaku, was developed and will be marketed by Switzerland-based Actelion (SIX: ATLN), Europe’s largest biotech company. Uptravi isis seen as a replacement for Actelion's mainstay PAH drug Tracleer (bosentan), which used to account for around 80% of the firm's sales but is now facing generic competition. Although the company’s shares initially gained round 2% on the news, they were barely changed at 134.60 Swiss francs by close of today.

Analysts at Barclays estimate peak sales for the new drug at about 2 billion Swiss francs (~$2 billion). However, Actelion will face competition from a new drug called Adempas (riociguat), sold by German rival Bayer (BAYN: DE) and marketing partner Merck & Co (NYSE: MRK). Adempas was approved by the FDA in 2013 and in Europe last December (The Pharma Letter December 8, 2014).