EMA backs market rollback of rare disease drug Tavneos over data concerns - Pharmaceutical Technology

The recommendation in Europe follows a similar move by the FDA earlier this year. The recommendation in Europe follows a similar move by the FDA earlier this year. The decision comes after the agency’s human medicines committee (CHMP) conducted a review to assess new information relating to the Phase III Advocate study. Credit: Gajus/Shutterstock.com. The European Medicines Agency (EMA) has recommended that marketing authorisation for Tavneos (avacopan) be revoked due to a question mark over the integrity of clinical data used to support its initial approval. The guidance comes after the agency’s human medicines committee (CHMP) conducted a review to…

Source: Pharmaceutical Technology