Actelion has submitted an application in Europe to market its investigational drug Uptravi (selexipag) as a treatment for pulmonary arterial hypertension.
The filing is based on data from the Phase III GRIPHON study involving 1,156 patients with the condition, which showed that the drug - the first selective oral IP prostacyclin receptor agonist originally discovered and synthesised by Nippon Shinyaku - decreased the risk of a morbidity/mortality event versus placebo by 39%.
In PAH, survival rates are unacceptably low and PAH remains incurable. “With selexipag, PAH specialists may be able to target the prostacyclin pathway with an oral therapy with long-term outcome benefits,” said Actelion chief Jean-Paul Clozel, and promised to “work closely with Health Authorities in order to be able to make this treatment available to the PAH community as quickly as possible”.
The most common adverse events in GRIPHON that occurred with higher frequency on Uptravi rather than placebo were in-line with those known in prostacyclin therapies; headache, diarrohea, nausea, jaw pain, vomiting, pain in extremity, myalgia, nasopharyngitis and flushing. The proportion of patients discontinuing treatment due to adverse events was 14% compared to 7% on placebo, the Swiss biotech noted.
An approval for the drug will cement Actelion’s dominant position in PAH. Last year, it received the green light on both sides of the Atlantic for Opsumit (macitentan), the follow-up to its hugely successful drug Tracleer (bosentan). Analysts predict it will be a blockbuster and offset declining sales of Tracleer which goes off-patent next year.