Monday, March 31, 2014

Bayer gets EU approval for lung-disease drug - MarketWatch

By Neetha Mahadevan



FRANKFURT--Bayer AG (BAYN.XE) said Monday its pulmonary hypertension drug, Adempas, has been approved by the European Commission for the treatment of two chronic forms of hypertension, chalking up another approval for one of its five key drugs.



Adempas, also known as Riociguat, is one of Bayer's five promising new drugs with a combined sales potential of EUR7.5 billion. Adempas, which alone has peak sales potential of more than EUR500 million annually, is the first and only drug approved for patients with chronic thromboembolic pulmonary hypertension, or CTEPH. The drug has also been approved to treat patients with pulmonary arterial hypertension, or PAH.



"With the approval of Adempas by the European Commission, an important new treatment option becomes available for patients with pulmonary hypertension in Europe," Bayer HealthCare's Head of Global Development Joerg Moeller said.



Adempas has been approved in the U.S. and Canada for both forms of pulmonary hypertension, while it was approved in Japan for CTEPH in January this year. In the European Union, riociguat has also been granted orphan drug designation.



Pulmonary hypertension is a severe, life-threatening disorder of the heart and lungs in which the blood pressure in the pulmonary arteries is above normal, and which can lead to heart failure and death.



Write to Neetha Mahadevan at neetha.mahadevan@wsj.com



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