Trials & Filings

Bayer Drug Granted Orphan Status

Riociguat to treat PAH, CTEPH

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Bayer HealthCare has received from the FDA two separate orphan drug designations for its investigational, oral medication riociguat (proposed trade name Adempas), for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The Orphan Drug Designation program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affe...

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