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Bayer’s Adempas Overcomes FDA Dosing Concerns To Win Approval

 
• By Sue Sutter

Riociguat becomes the first therapy indicated for chronic thromboembolic pulmonary hypertension in the U.S. Labeling includes Bayer’s recommended starting and maximum doses but provides the option for a lower starting dose in patients who may not tolerate the hypotensive effects, a concern for agency reviewers.

FDA approved Bayer HealthCare LLC’s novel vasodilator Adempas (riociguat) Oct. 8 with labeling that reflects the higher dosing schedule proposed by the sponsor despite agency reviewers’ reservations about the risks of hypotension with the suggested dose.

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