The European Medicines Agency requests the withdrawal of a medicine after becoming aware of misleading data and serious side effects.
European health authorities are preparing to withdraw a drug from the market following a reassessment of its benefit-risk ratio. “Its benefits are no longer proven to outweigh its risks” underlines the National Medicines Agency (ANSM) in a press release dated June 26. What’s more “the study data provided at the time of the evaluation of the marketing authorization application proved to be incorrect and misleading, and can no longer be considered reliable”. If the European Commission confirms this recommendation, the treatment will no longer be able to be marketed in the European Union and therefore in France.
In addition to having been marketed on the basis of faulty data, the drug is associated with serious risks. The ANSM confirms “an increased risk of liver injury and missing bile duct syndrome (…) including fatal cases”. In May, its manufacturer reported the deaths of twenty people. “Severe damage appears especially in the first three months” he then explained. The functioning of the liver of patients must be “closely monitored until treatment is definitively stopped” recommend the authorities, and “no new patients should start treatment”.
This medicine is Tavneos® (avacopan). It is indicated in the treatment of two severe forms of vasculitis in adults: granulomatosis with polyangiitis and microscopic polyangiitis. These diseases are rare. Their prevalence is estimated at around 100 cases per million inhabitants in France, or 6,000 to 7,000 people. Patients already treated must be contacted quickly in order to organize a switch to another therapeutic option. The agency also reminds that they should not stop their treatment on their own initiative, but consult their doctor.
Monitoring of liver function should be continued until treatment is definitively stopped, due to the risk of serious liver damage. “If you take Tavneos® and you have questions, talk to your doctor.” recommends the ANSM. Tavneos® has been authorized in France since January 11, 2022 and available only by prescription. DPending the final decision of the European Commission, the ANSM asks French doctors not to start any new treatment.
