FDA Review Of Bayer’s Riociguat Suggests It’s All About The Dose
This article was originally published in The Pink Sheet Daily
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.
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.
Impressive Phase III trial data on Actelion’s macitentan and Bayer’s riociguat generated big noises at the annual meeting of the American College of Chest Physicians in Atlanta and should support regulatory filings for the two therapies.
Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.