**Title: Bayer’s Riociguat Secures FDA Priority Review for Pulmonary Hypertension**
Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational drug riociguat, granting it priority review status. This designation is pivotal for the potential treatment of two critical conditions: Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH), including cases deemed inoperable or with persistent/recurrent symptoms post-surgery.
Riociguat, an oral compound, has shown promise in addressing these severe, life-threatening conditions by targeting the soluble guanylate cyclase (sGC) pathway, an important mechanism in vascular regulation. The priority review status accelerates the FDA’s review process, typically reducing it from 12 months down to 6 months, reflecting the agency’s belief in riociguat’s potential to meet significant unmet medical needs.
PAH and CTEPH are rare conditions leading to high blood pressure in the lungs, resulting in substantial morbidity and mortality largely due to the heart’s increased workload. The innovative mechanism of action of riociguat offers a new therapeutic pathway distinct from existing treatments, which bodes well for patients who have few effective alternatives.
If approved, riociguat could represent a significant breakthrough, expanding Bayer’s cardiovascular portfolio and offering hope to thousands of patients. Investors and market watchers