France-based Ipsen (EPA: IPN) has announced that it has received marketing clearance from the National Medical Products Administration (NMPA) of China for its drug odevixibatto, trading under the name Bylvay. The drug is indicated for treating itching in patients with progressive familial intrahepatic cholestasis (PFIC) who are aged six months and above. This approval follows the European Union’s nod for the same indication in 2021.
Odevixibatto: A Reversible Ileal Bile Acid Transporter (IBAT) Inhibitor
Odevixibatto is a reversible ileal bile acid transporter (IBAT) inhibitor that has been developed to address the specific needs of patients suffering from PFIC. The drug works by inhibiting the IBAT, thereby reducing the reabsorption of bile acids in the ileum and potentially alleviating the symptoms of the disease, including itching.
Access to Hainan’s Medical Tourism Pilot Zone
Prior to this national approval, odevixibatto had gained access to the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province, providing an early opportunity for patients in China to benefit from this treatment. The expansion of access to the drug across China represents a significant step forward in improving the standard of care for patients with PFIC.-Fineline Info & Tech
