Orphan Drugs: Global Regulatory Events

This Blog Post discusses recent global non-US regulatory events for orphan drugs.

I – Europe

At a January meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gives the following opinions for three orphan drugs :

•   Positive recommendation for Bayer’s Adempas (Riociguat) for the treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension (PAH)