Tavneos Approved in EU as Oral Add-on Treatment for MPA, GPA
The European Commission has approved Tavneos (avacopan) as an add-on therapy for adults with severe granulomatosis polyangiitis (GPA) or microscopic polyangiitis (MPA) — the two main types of ANCA-associated vasculitis (AAV).
Following the expected launch this year, Tavneos will be the first available oral therapy for GPA and MPA approved in the European Union (EU).
The approval, granted to Vifor Fresenius Medical Care Renal Pharma, follows a recommendation from the European Medicines Agency last fall.
“The European Commission’s approval of Tavneos is a milestone for the treatment of ANCA-associated vasculitis in Europe and for patients living with this debilitating disease,” Klaus Henning Jensen, MD, chief medical officer of Vifor Pharma, said in a press release.
Tavneos has been approved in the U.S. and Japan.
Normally, the complement system is involved in recruiting immune cells to areas of injury or infection. In AAV, the complement system is wrongly activated, initiating an immune response in healthy tissues.
Tavneos is an oral small molecule that inhibits C5a — an important protein involved in complement system signaling — therefore preventing the inappropriate recruitment of immune cells to healthy areas. In doing so, C5a can help prevent the inflammation and blood vessel damage that’s characteristic of AAV.
Previously, Tavneos was designated an orphan drug for AAV treatment in Europe, a designation that helps to speed progress towards development and approval of therapeutics for rare diseases.
The European approval was based on results of promising clinical trials, culminating with the ADVOCATE Phase 3 trial (NCT02994927).
ADVOCATE’s goal was to determine whether Tavneos could replace conventional steroid therapy, like prednisone, in AAV treatment regimens. Steroids are commonly used in combination with other therapies for AAV but can be accompanied by side effects.
Results showed that Tavneos was an effective alternative to steroids, leading to sustained disease remission at 52 weeks, and outperforming steroids in improving kidney function.
Tavneos is intended as an add-on therapy, meaning it is given in combination with either rituximab or cyclophosphamide, the standard immunomodulatory therapies for AAV.
“This is a significant step forward for patients in Europe living with this systemic condition,” said David Jayne, MD, professor of clinical autoimmunity at the University of Cambridge. “They will now have available a new class of medication that meets major unmet medical needs in the treatment of ANCA-associated vasculitis.”
Tavneos was first developed by ChemoCentryx, a U.S.-based company which owns commercial rights for the therapy in the U.S. ChemoCentryx granted Vifor Pharma the rights to Tavneos in nearly all other countries. Vifor Pharma later gave an exclusive license to Kissei Pharmaceuticals to commercialize the therapy in Japan.
The European approval means that Tavneos can be marketed in all states of the European Union, in addition to Iceland, Liechtenstein, and Norway.
“We look forward to working with EU member states to provide access to this important medicine, with first launches expected in the first half of 2022,” Jensen said. “We are confident that Tavneos can become part of the new standard of care supporting better outcomes for patients, a better quality of life, and reduce the challenging side-effects of current treatment options.”
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