The Saudi Food and Drug Authority (SFDA) has announced the suspension of the registration for the drug (Avacopan), commercially known as Tavneos. This decision is part of the authority’s ongoing regulatory procedures and post-marketing surveillance to monitor the safety and efficacy of pharmaceutical products, thereby enhancing patient protection and upholding the highest standards of drug safety.

The SFDA explained that the decision follows a comprehensive scientific review conducted by specialized technical committees, which analyzed the latest scientific data and international regulatory reports. The re-evaluation of the balance between the drug's benefits and risks revealed new developments, including reports of liver injury in some patients. Considering these risks, alongside the drug's limited local use and the availability of safer alternative treatments, the SFDA has suspended its registration as a precautionary measure until all relevant scientific and regulatory data are fully verified.

The authority indicated that the suspension was finalized following a scientific evaluation by pharmacovigilance and drug safety experts. The official decision was issued by the Pharmaceutical Companies and Factories Registration Committee under resolution number (48/SFDA/1269/61).

The SFDA emphasizes that patients should not discontinue their treatment without consulting their doctor to discuss alternative options.

The SFDA clarified that while product registration is initially granted based on scientific and clinical data available at the time of application, it undergoes continuous periodic reviews as new information emerges that might require re-evaluation. This proactive measure reflects the strength of the post-marketing monitoring system for pharmaceutical products, which ensures the continuous follow-up of the safety and efficacy of drugs and tracks local and international scientific developments, enhancing alignment with the best global regulatory practices.

The SFDA reiterates its commitment to transparency by keeping patients and healthcare practitioners informed of critical regulatory updates. The authority remains dedicated to monitoring all pharmaceutical products registered in Saudi Arabia and taking swift regulatory action when necessary to protect public health and support evidence-based medical decisions.