Britain’s medicines regulator announced on Tuesday that it is suspending the use and sale of Amgen’s rare‑disease medication Tavneos for any new patients. The decision follows the regulator’s finding that the primary clinical trial used to approve the drug was unreliable, meaning the study can no longer demonstrate that the drug works or that its benefits outweigh its risks.
What is Tavneos and how it is used?
Tavneos, marketed in the United Kingdom as Avacopan Vifor by CSL Vifor, is prescribed alongside other medicines to treat severe autoimmune conditions that cause inflammation of small blood vessels. These diseases can lead to serious damage to the kidneys and lungs.
Regulatory actions and timeline
The regulator said the unreliable data from the main trial means the study cannot confirm the drug’s efficacy. It plans to formally revoke the UK approval on March 1, 2027. Patients already receiving Tavneos may continue treatment for up to six months, but doctors are advised to consider alternative therapies and to ensure patients do not stop treatment without consulting a specialist.
Background on the drug and its ownership
Tavneos was originally developed by ChemoCentryx, which Amgen acquired for $3.7 billion in 2022. Amgen retains the U.S. rights to the drug, while CSL Vifor holds commercial rights in selected markets outside the United States, including the United Kingdom.
International regulatory scrutiny
Earlier this year, the European Commission revoked Tavneos’ approval after regulators also found the key trial data unreliable. In the United States, the Food and Drug Administration has proposed withdrawing the drug, citing unproven effectiveness and false statements in the original application. Amgen is contesting the proposed U.S. withdrawal and has submitted more than 70 studies involving over 2,200 patients in an effort to address regulators’ concerns.
Clinical findings and safety concerns
An independent review found that Tavneos performed similarly to steroid‑based treatment at 26 and 52 weeks, but it did not demonstrate superiority at the 52‑week mark. Additionally, the U.S. FDA has linked Tavneos to 76 cases of serious liver injury, including eight deaths.
Implications for patients and providers
Healthcare providers in the United Kingdom are now tasked with reviewing treatment plans for patients currently on Tavneos and identifying suitable alternatives. The regulator emphasized that patients should not abruptly discontinue the medication without medical guidance.
While the suspension applies only to new patients, the ongoing investigations and potential revocation highlight the importance of rigorous clinical data in the approval process for life‑saving medicines.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
