Actelion Planning to Expand Its PH Portfolio

Switzerland-based Actelion, developer of two approved pulmonary arterial hypertension (PAH) drugs Opsumit (macitentan) and, more recently, Uptravi (selexipag), announced that it will present updates on company growth and future plans at investor conferences in the near future.

Actelion is in the process of transforming is PAH portfolio and developing its R&D pipeline of potential treatments for a range of diseases.

Uptravi is an orally administered prostacyclin receptor agonist, and was approved by the FDA in December 2015 for the treatment of PAH. The drug, which became commercially available in the U.S. on Jan. 4, 2016, aims to delay PAH progression and reduce the risk of patient hospitalization.

Actelion said in a company press release that regulatory reviews of Uptravi are now underway in Europe, Canada, Australia, New Zealand, Switzerland, Turkey, Taiwan and South Korea.

“Our PAH franchise has evolved from a single product into a portfolio of unique and complementary products, which cover the continuity of care in this severe disease. The dynamics of this transformation is reflected in the performance of our products in the market. Opsumit has had a highly successful launch and we are confident to continue this momentum into 2016,” said Otto Schwarz, chief operating officer of Actelion.

Opsumit, already in use for PAH, is currently going through clinical trials to evaluate its safety and tolerability in individuals with combined pre-­ and post-­capillary pulmonary hypertension (CpcPH) associated with left ventricular dysfunction.

Initial, encouraging results of the Phase 2 study of Opsumit recently became available, showing that the drug was well-tolerated in a group of pulmonary hypertension patients with heart failure. The company announced that it will now fully analyze the data and, taking into account data from a current Phase 2 study of a new endothelin receptor antagonist (ERA), make a decision concerning the future developmental strategy of its ERAs, beyond the treatment of PAH.

Jean-­Paul Clozel, chief executive officer of Actelion, said, “With the impressive take-­off of Opsumit (macitentan) and now Uptravi (selexipag) on the market, we have a great platform to invest in our future.”