- The FDA on Tuesday approved Uptravi (selexipag) for treatment of patients with pulmonary arterial hypertension (PAH). The drug was approved to delay disease progression and reduce the risk of hospitalization in patients with PAH.
- Actelion plans to make the drug available in the U.S. in January 2016.
- Uptravi is being positioned as a treatment option for patients who have already been through first-line therapy, usually with an endothelin receptor antagonist (ERA). Actelion markets another drug, Veletri, which is generally reserved for the sickest patients.
A year ago, BioPharma Dive tagged Uptravi as one of the biggest launches of 2015. Although Uptravi is a little late out of the gate, prospects remain positive for a strong launch in the first quarter of next year. Transparency Market Research has forecast the global PAH market will be $5.19 billion by 2020.
Uptravi's first-year sales are forecast at $1.245 billion, meaning it could reach blockbuster status.
Whether this target is achievable remains to be seen, but there are two major factors working in Actelion's favor. First, Actelion has a major presence in the PAH market, stemming from previous success with the blockbuster drug Tracleer, an ERA which lost patent protection last year.
Furthermore, Uptravi has been very carefully positioned as a second-line treatment with a powerful sales & marketing team behind it.