FDA Panel Endorses Riociguat For CTEPH Amid Worries It Will Displace Surgery
Committee unanimously recommends Bayer’s Adempas for two indications, but members say measures are needed to ensure that patients with chronic thromboembolic pulmonary hypertension are not automatically steered to the novel vasodilator when they could benefit from potentially curative surgery.
You may also be interested in...
Bayer has filed riociguat, a first-in-class oral soluble guanylate cyclase stimulator, in the U.S. and Europe for approval in both pulmonary arterial hypertension and a related condition, persistent/recurrent chronic thromboembolic pulmonary hypertension. The compound stands to become the first drug therapy approved for CTEPH.
Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.
Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.