Bayer Wins EU Panel Backing for Lung Drug After FDA Approval

Bayer AG (BAYN)’s lung medicine Adempas won backing from the European Union drug regulator to treat patients with two types of pulmonary hypertension, clearing the way for approval.

Bayer’s drug, also known as riociguat, should be approved for the treatment of both chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension, the European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement today. High blood pressure in the arteries to the lungs characterizes both varieties of the disorder, putting patients at risk for fatal heart failure.

Adempas may generate 413 million euros ($566 million) in sales by 2017, according to the average of eight analysts’ estimates compiled by Bloomberg. Approved last year in the U.S., the drug is the first to treat CTEPH, the chronic form of pulmonary hypertension. Doctors had relied on a complex surgery to help such patients.

Approval would position Bayer, based in Leverkusen, Germany, to compete with Switzerland’s Actelion Ltd. (ATLN) on PAH, the second, more common condition, in Europe as well as the U.S.

Actelion, based in Allschwil, won approval in the U.S. and Europe last year for a new therapy, Opsumit, to add to a portfolio anchored by its best-selling drug Tracleer.

Unlike CTEPH patients, people with PAH already have a range of available therapies, including Opsumit, Tracleer and Pfizer Inc. (PFE)’s Revatio.

Both conditions increase pressure in arteries leading to the lungs. CTEPH results from blood clots in arteries leading to the lungs. Meanwhile, in PAH the blood vessels stiffen for a reason doctors haven’t yet been able to identify.

The European Commission, the EU’s executive arm, usually follows the EMA committee’s recommendations.

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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