The Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing the benefits and risks of avacopan (Avacopan Vifor, previously known as Tavneos), which is used in the treatment of some rare autoimmune diseases affecting small blood vessels. This review has been prompted by information that raises questions about the integrity and reliability of the data from the pivotal clinical study underpinning the licence approval.
The MHRA review is considering at whether this information changes what the study showed about the effectiveness of avacopan, and what this means for the overall benefit-risk consideration of the product.
Avacopan, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are rare autoimmune diseases affecting small blood vessels.
The review is being undertaken under the Human Medicines Regulations 2012 Section 68 which states that the licensing authority, the MHRA, may revoke, vary or suspend a UK marketing authorisation if the licensing authority considers that the application, or the material supplied with it, is incorrect or no longer supports a positive benefit–risk balance for the product.
The existing risk minimisation advice in the product information continues to apply while the review is undertaken. This includes monitoring of liver function and white blood cell count, as well assessing patients for any serious infections.
While the review is ongoing, healthcare professionals are reminded to consider carefully the individual patient benefits and risks regarding the use of avacopan.
Patients are advised to not stop treatment without consulting their healthcare professional.
The outcome of the review, including any new advice to healthcare professionals and patients, will be communicated once the review is complete.
Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.