France has recalled all remaining stocks of Tavneos, a drug used to treat rare autoimmune diseases, after European regulators withdrew its marketing authorization.
The decision follows concerns about the drug’s clinical trial data and reports of serious liver injuries, including deaths.
France orders Tavneos recall
France’s medicines safety agency, the ANSM, said Vifor France would recall all remaining batches of Tavneos 10 mg capsules from August 19.
The move comes after the European Commission withdrew the drug’s authorization across the European Union on August 4.
As a result, doctors in France must no longer start or renew Tavneos prescriptions. Pharmacists have also been told to stop dispensing the medicine.
What is Tavneos?
Tavneos, also known as avacopan, was approved for adults with severe active granulomatosis with polyangiitis and microscopic polyangiitis.
Both conditions are forms of ANCA-associated vasculitis. These rare autoimmune diseases cause the immune system to attack blood vessels.
In serious cases, the conditions can damage major organs, including the kidneys and lungs.
Regulators raise concerns over clinical trial data
European regulators reviewed Tavneos after concerns emerged about data from the ADVOCATE clinical trial, which supported the drug’s approval.
The European Medicines Agency said the study involved serious breaches of good clinical practice.
In addition, regulators found that some information submitted during the approval process was incorrect or misleading.
Therefore, the agency concluded that the available evidence could no longer reliably show that Tavneos’ benefits outweighed its risks.
Liver injury cases increase safety concerns
Concerns also grew after reports of serious liver injuries among patients taking Tavneos.
In Japan, Kissei Pharmaceutical reported 20 fatal cases of serious liver injury among more than 8,500 patients who received the drug.
However, Amgen, which owns the U.S. rights to Tavneos, said a direct link between the medicine and every reported death had not been established.
The U.S. Food and Drug Administration has also raised concerns about Tavneos. Earlier this year, the agency identified dozens of serious liver injury cases linked to the drug, including fatal outcomes.
The FDA has also proposed withdrawing Tavneos’ U.S. approval because of concerns about the clinical trial data.
Patients advised to contact doctors
French authorities are telling patients not to stop taking Tavneos without medical advice.
Instead, patients who still use the medicine should contact their prescribing doctor as soon as possible. Doctors can then discuss alternative treatment options and arrange a safe transition to another therapy.
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