Actelion Gets US FDA Nod For New PAH Drug Uptravi To Complement Tracleer

Actelion, Europe's biggest biotech firm, will bring its new drug for the treatment of pulmonary arterial hypertension (PAH) to the United States in early January, the company announced in a statement Tuesday.

The Swiss drugmaker has won approval from the U.S. Food and Drug Administration to launch Uptravi (selexipag) in the U.S. market, a follow-up drug to its original blockbuster drug, Tracleer. Actelion dominates the market for drugs that treat PAH, a disease that weakens the heart.

"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," Actelion CEO Jean-Paul Clozel said in the statement, referring to the company’s other PAH drugs such as Opsumit and Veletri.

The company has been focusing on the development of new PAH drugs to reduce its reliance on Tracleer, its original blockbuster drug that lost its U.S. patent protection this year.

The Swiss company said that Uptravi will delay the disease's progression and reduce risk of hospitalization for PAH patients. The selexipag compound was originally discovered and synthesized by Nippon Shinyaku, a Japanese pharmaceuticals company with whom Actelion has had an exclusive worldwide alliance since April 2008.

Uptravi could reach blockbuster status and hit annual sales of $1 billion or more in the U.S., Reuters reported, citing analysts. Its main competition is Adempas, sold by German rival Bayer and marketing partner Merck & Co.

Actelion is working with health authorities to obtain regulatory approval to sell Uptravi outside the U.S., the company said in the statement.