U.S./EU Filings Position Bayer Compound As First Approval For CTEPH
This article was originally published in Pharmaceutical Approvals Monthly
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.
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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.
Agency will seek Cardiovascular and Renal Drugs Advisory Committee’s views on a dosing algorithm for the novel pulmonary arterial hypertension drug; FDA clinical reviewer recommends approval but with lower starting and maximum doses than those used in the pivotal trials due to risk of drug-induced hypotension.
It’s all change at two of Europe’s largest pharmaceutical concerns as leading light Daniel Vasella retires at Novartis and Bayer Healthcare’s chairman Jorg Reinhardt moves across to replace him as non-executive chairman.