Tavneos Gains Nod from NICE as Treatment for Two Main Forms of AAV

The National Institute for Health and Care Excellence (NICE) has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen as a treatment for adults with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the two main forms of ANCA-associated vasculitis (AAV).

Announced by Vifor Fresenius Medical Care Renal Pharma (VFMCRP) in an Aug. 18, 2022 press release, the decision by NICE follows on from the authorization by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022. Both decisions, of NICE and MHRA, were based on findings from a comprehensive development program that ended with the results from a Phase III trial, which demonstrated non-inferiority of Tavneos when compared with prednisolone at remission of disease over 26 weeks and then superiority of the former when sustaining remission at 52 weeks.

“ANCA-associated vasculitis is a rare, systemic disease which can be rapidly fatal if not appropriately and promptly treated. The variable nature of the disease and its course along with challenging side-effects of current treatment options can severely affect subsequent quality of life for patients,” said John Mills, vice-chair of Vasculitis UK, in the press release. “We very much welcome NICE’s decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition.”

“NICE’s decision represents a major advancement for the treatment of GPA/MPA in the UK,” added David Jayne, professor of Clinical Autoimmunity, University of Cambridge, in the press release. “Patients will now have access to a new therapy option that could help them optimize their treatment outcomes.”

“We are delighted about this recommendation for patients in England, Wales, and Northern Ireland living with GPA/MPA,” said Klaus Henning Jensen, chief medical officer of CSL Vifor. “It means that an underserved patient population will have access to a first-in-class treatment aiming to meet major unmet medical needs. We look forward to continue working with the National Health Service to ensure access to this important medicine for patients across the UK as quickly as possible.”

Source: CSL Vifor