Meditip withdraws Tavner license in South Korea following EU revocation

Meditip has decided to withdraw its domestic marketing authorization for Tavner (avacopan), a treatment for rare autoimmune diseases, following the revocation of its license in Europe.

Although the drug had passed the drug benefit evaluation by the Health Insurance Review and Assessment Service and was in price negotiations with the National Health Insurance Service, the decision follows concerns regarding the reliability of clinical data. The European Medicines Agency (EMA) recommended the withdrawal of the product after finding that the ADVOCATE Phase 3 clinical trial data contained inaccuracies and violated Good Clinical Practice (GCP) standards.

Tavner was intended to serve as a new treatment option for adults with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), potentially reducing the need for high-dose steroids. The withdrawal effectively halts its inclusion in the South Korean national health insurance system.