Tavneos Soon Will Be Available in UK as Add-on Therapy for Vasculitis

NICE recommends Tavneos for AAV in England, Wales, and Northern Ireland

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by Steve Bryson, PhD |

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Tavneos (avacopan) will soon be available as an add-on treatment for adults in England, Wales, and Northern Ireland with severe, active granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA), the two main types of ANCA vasculitis (AAV), following a decision by regulatory authorities.

The National Institute for Health and Care Excellence (NICE) in the U.K. recommended the oral small molecule to be used as a combination therapy for AAV patients.

That recommendation comes on the heels of an announcement of the therapy’s marketing authorization from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) in May.

The launch of Tavneos — to be used along with rituximab or cyclophosphamide — is expected in a few weeks.

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

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Tavneos, also available in the U.S., Canada, and the European Union, is an oral treatment designed to block the activation of the complement system, a group of immune-related proteins that plays a role in the autoimmune attacks seen in ANCA vasculitis.

Both the MHRA approval and the NICE recommendation were supported by data from the Phase 3 ADVOCATE trial (NCT02994927), which tested the therapy in 331 people with AAV.

ADVOCATE’s primary goal was to determine whether Tavneos could replace conventional steroid therapies, such as prednisone, in AAV treatment regimens. Although steroids are commonly used in combination with other AAV therapies, their prolonged use can lead to serious side effects.

Trial data showed that Tavneos reduced disease activity after about one year of treatment, and worked better than prednisone to improve kidney function in patients with severe kidney disease.

“ANCA-associated vasculitis is a rare, systemic disease which can be rapidly fatal if not appropriately and promptly treated,” said John Mills, vice-chair of Vasculitis UK, a nonprofit advocacy group. “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.”

“We very much welcome NICE’s decision, which means that eligible patients and clinicians have another choice of treatment for this debilitating condition,” added Mills.

Tavneos was first developed by the U.S.-based ChemoCentryx, which owned the therapy’s commercial rights in that country. ChemoCentryx is now being acquired by Amgen.

Marketing authorization was granted to Vifor Fresenius Medical Care Renal Pharma (VFMCRP), which has a licensing agreement with ChemoCentryx to commercialize Tavneos outside the U.S.

“We are delighted about this recommendation for patients in England, Wales and Northern Ireland living with GPA/MPA,” said Klaus Henning Jensen, MD, chief medical officer of CSL Vifor, VFMCRP’s joint company. “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,” Jensen added.