By Fineline Cube 
France‑based Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced the official commercial launch of its rare‑disease innovation, BYLVAY (odevixibat capsules), in China. The rollout represents a major milestone in expanding access to therapy for Progressive Familial Intrahepatic Cholestasis (PFIC), a rare inherited liver disorder.
Regulatory Milestone
- NMPA Approval – BYLVAY received approval from China’s National Medical Products Administration in December 2024 for the treatment of pruritus in PFIC patients ≥ 6 months of age.
- First‑in‑Class Position – As the first and only non‑surgical, targeted drug approved in China for PFIC, BYLVAY offers a safe, effective, and non‑invasive alternative to liver transplantation.
Disease Landscape
PFIC affects 1–2 per 100,000 live births, typically presenting in the neonatal period or first year of life. Clinical features include jaundice, intense itching, elevated serum bile acid levels, malabsorption, and developmental delays. Without timely intervention, the condition can progress to end‑stage liver disease, often necessitating transplant.
Ipsen’s Strategic Impact
By introducing BYLVAY to the Chinese market, Ipsen expands its global footprint in orphan‑drug development and reinforces its commitment to delivering innovative solutions for underserved patient populations. The launch underscores the company’s focus on bridging regulatory gaps and accelerating access for life‑changing therapies worldwide.-Fineline Info & Tech