Actelion European MAA for PAH Drug Selexipag Pending Approval

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Microvasculature and CTEPHActelion Pharmaceuticals Ltd., has just announced its has sent the European Medicines Agency (EMA) an application for the centralized Marketing Authorization of selexipag (Uptravi®), indicated for the treatment of pulmonary arterial hypertension (PAH). While the drug’s MAA is pending validation, the company is working on submissions to the US Food and Drug Administration and other regulatory agencies across the globe.

This potent, oral, selective IP prostacyclin receptor agonist was originally formulated by Japanese company Nippon Shinyaku. By selectively targeting prostacyclin receptors, Selexipag induces vasodilation and prevents the proliferation of vascular smooth muscle cells. Nippon Shinyaku signed a global alliance with Actelion last April 2008 to collaborate on the drug, with Actelion spearheading drug development and commercialization outside Japan.

The MAA application cites findings from a kay Phase III GRIPHON trial that enrolled 1,156 PAH patients from 181 centers across 39 countries in North and Latin America, Europe, Asia-Pacific and Africa, and tested the long-term efficacy and safety of Selexipag. According to a report published June 2014, Selexipag reduced the risk of morbidity/mortality in PAH patients by 39 percent, compared to those who received a placebo. Treatment response was consistent across patient subgroups (age, gender, WHO Functional Class, PAH etiology and background PAH therapy) treated for up to 4.2 years.

Actelion’s Chief Executive Officer, Dr. Jean-Paul Clozel, said they are pleased to submit a European MAA for a highly effective drug such as Selexipag. “With selexipag, PAH specialists may be able to target the prostacyclin pathway with an oral therapy with long-term outcome benefits. We will work closely with Health Authorities in order to be able to make this treatment available to the PAH community as quickly as possible.”

In other news on PAH, RegeneRx Biopharmaceuticals, Inc. recently published a report in the journal PlosOne on a study of Thymosin beta 4 (TB4), a protein that has shown the potential to reduce or even prevent heart failure in mice with PAH. The company’s chairman and chief scientific advisor commented, TB4 is a promising vasculoprotective agent for the treatment of PH-induced cardiac failure and corroborates other independent studies demonstrating the reduction of damage and improvement in acute and sub-chronic cardiac models.

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