Bayer's PAH drug candidate riociguat gets US priority review; Sativex rescheduled in UK

8 April 2013

The US Food and Drug Administration has granted priority review to German drug major Bayer’s (BAYN: DE) New Drug Application for the oral investigational drug riociguat, intended for the treatment of pulmonary hypertension.

Bayer HealthCare recently submitted riociguat, the first drug to demonstrate efficacy in two distinct forms of pulmonary hypertension (inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) for regulatory approval in the USA and in the European Union (The Pharma Letters March 31 and February 12).

Assuming eventual market approval for riociguat, the drug would join a PAH market expected to grow to a value of $3.57 billion by 2015, according to GlobalData. The current market is dominated by Tracleer (bosentan) – due to lose patent protection in 2015 - from Switzerland’s Actelion.

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