Actelion's Uptravi Received FDA Approval, to Enter U.S. Market in January
December 22, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Allschwil, Switzerland-based Actelion announced today that its drug Uptravi (selexipag) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH).
The company has plans to launch the drug in January 2016, and will be hosting an investor conference call and webcast on Jan. 5, 2016.
Uptravi is an oral, selective IP prostacyclin receptor agonist. It was originally discovered and synthesized by Kyoto, Japan-based Nippon Shinyaku. Analysts have indicated that the drug has the promise of becoming a blockbuster, with annual sales exceeding $1 billion or more.
PAH is a chronic, life-threatening disease with primary symptoms being abnormally high blood pressure in the arteries between the heart and lungs. Symptoms are typically non-specific and range from mild breathlessness and fatigue during normal activity to right heart failure and severe restrictions on exercise capacity.
“Today’s FDA approval of Uptravi is another major landmark for Actelion,” said Jean-Paul Clozel, chief executive officer of Actelion, in a statement. “Together with our partners at Nippon Shinyaku we are proud to be able to offer an outstanding oral therapy targeting the prostacyclin pathway. The label for Uptravi recognizes the improvement in long-term outcomes, including reducing the risk of hospitalization for PAH regardless of whether patients received background therapy including an ERA, a PDE-5 inhibitor, or — for the first time ever in PAH—on top of a combination of both, an ERA and a PDE-5 inhibitor.”
So far the drug has not been approved outside the U.S. The drug will face competition from Bayer and Merck & Co. ’s drug, Adempas. Adempas was approved by the FDA in late 2013 to treat two forms of pulmonary hypertension.
“The prostacyclin pathway has long been recognized as a key target in PAH treatment,” said Vallerie McLaughlin, director of the Pulmonary Hypertension Program in the Division of Cardiovascular Medicine at the University of Michigan, in a statement. “However, until now, it has been underutilized. This is in part due to the significant burden existing prostanoid treatments have placed on the patients and on those supporting them. The approval of Uptravi with its convincing long-term outcome results means that many more patients can benefit from this pathway and be treated much earlier in the course of their disease.”
In part, Uptravi’s approval was based on data from the GRIPHON study, a Phase III clinical trial that evaluated 1,156 patients for up to 4.2 years. It indicated that the “primary composite endpoint was reduced by 40% with selexipag compared to placebo.”
Actelion has had its ups and downs this year, and took a short bump after the news of this approval. Shares traded on Jan. 22 for $134.80, rose to $146.20 on July 16, then dropped to $115.90 on Oct. 14. Shares then recovered to $144.50 on Nov. 30, dropped again on Dec. 14 to $129.60. They are currently trading for $134.70 per share.