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.
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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.
Citing considerations of simplification, implementation and equity, Advisory Committee on Immunization Practices says everyone ages ≥50 years should get an mRNA vaccine booster dose and recommends all individuals ≥18 years have the option of getting one, without regard to occupational exposure or underlying medical conditions.
Emergency use authorization for Pfizer/BioNTech, Moderna vaccine boosters for everyone ≥18 years was based on the same immune response data that supported previous clearance in certain high-risk groups, although FDA said it also considered additional real-world data on myocarditis risk and the recent increase in COVID-19 cases.