Actelion ready to launch Uptravi after FDA approval
pharmafile | December 22, 2015 | News story | Research and Development, Sales and Marketing | Actelion, FDA, Jean-Paul Clozel, Uptravi, pulmonary arterial hypertension, selexipag
Actelion says it is ready to launch Uptravi, its drug for pulmonary arterial hypertension in the US in January, after it gained the OK from the US FDA.
The drug regulator approved Uptravi (selexipag) as a treatment to delay disease progression and reduce risk of hospitalisation in people with pulmonary arterial hypertension (PAH). The orally active, selective IP prostacyclin receptor agonist was originally discovered and synthesised by Nippon Shinyaku.
Actelion says it expects Uptravi to become available to patients in the United States in early January 2016. In other markets, Actelion “continues to work with health authorities to obtain regulatory approval for Uptravi,” it says.
The Swiss drugmaker is a dominant player in the PAH market, and has been looking for new drugs to cut its heavy reliance on its original blockbuster Tracleer (bosentan), which came off patent in the US in November 2015. Analysts have said that Uptravi could reach blockbuster status, meaning annual sales of $1 billion or more. Its main rival is Bayer and MSD’s Adempas (riociguat).
Jean-Paul Clozel, chief executive of Actelion, comments: “[The] FDA approval of Uptravi is another major landmark for Actelion. 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 hospitalisation for PAH regardless of whether patients received background therapy.”
Clozel added: “Uptravi will significantly expand the options to delay disease progression after initiation of therapy with a baseline treatment like Opsumit (macitentan) and well ahead of Veletri (epoprostenol sodium) for the late disease stage. Actelion now has an unparalleled portfolio of treatments across the continuum of care in PAH that offer a combination of long term-efficacy, safety and convenience.”
PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. It is a serious illness that becomes progressively worse and is sometimes fatal.
Lilian Anekwe
Read Black Swan’s analysis of the market for pulmonary arterial hypertension over the next 10 years, in the Black Swan Analysis epiomic epidemiology series forecast report on pulmonary hypertension in 8 major markets. To find out more and purchase the report go to www.pharmafile.com/market-reports.
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