Tavneos approved in Australia as add-on therapy for GPA, MPA
Approval covers Tavneos in combination with rituximab or cyclophosphamide
Tavneos (avacopan) has been approved in Australia as an add-on oral therapy for adults with two main types of ANCA-associated vasculitis (AAV): microscopic polyangiitis (MPA) and granulomatosis polyangiitis (GPA).
The approval from Australia’s Therapeutic Goods Administration specifically covers the use of Tavneos in combination with rituximab or cyclophosphamide, and establishes it as the first targeted therapy for AAV approved in a decade.
Tavneos received the agency’s orphan drug designation, which is meant to accelerate the clinical development and regulatory review of medicines that prevent or treat life-threatening or disabling diseases affecting fewer than 2,000 people in Australia.
Tavneos expected to become available in Australia in second half of this year
The regulatory approval follows similar decisions in the U.S., Canada, the European Union, the U.K., Switzerland, the United Arab Emirates, and Japan.
In the U.S., the therapy is marketed by Amgen’s subsidiary ChemoCentryx, its original developer. Outside the U.S., Vifor Fresenius Medical Care Renal Pharma (VFMCRP) holds the commercialization rights.
The oral therapy is expected to become available in Australia in the second half of this year.
“This is a pleasing result, and we are committed to bringing this new treatment option to Australian patients living with AAV,” James McDonnell, general manager of CSL Vifor Australia and New Zealand, VFMCRP’s joint company in Australia, said in a company press release.
CSL Vifor plans to file an application for Tavneos to be considered under Australia’s Pharmaceutical Benefits Scheme, a governmental program to subsidize and make medicines more affordable.
“We expect to make a submission to the Pharmaceutical Benefits Advisory Committee as soon as possible, reinforcing our on-going commitment to improving the care of patients living with this rare disease,” McDonnell added.
Tavneos works by lessening inflammation and injury to small blood vessels, a hallmark of AAV. This is caused by the abnormal activation of the complement system, a part of the immune system that goes awry in patients.
We are confident that this novel therapy will provide more options to help control the disease, extend remission and meet major unmet medical needs in the treatment of AAV.
Approval based on findings of global Phase 3 ADVOCATE trial
The treatment’s approvals were mainly based on findings from the global Phase 3 ADVOCATE trial (NCT02994927), which recruited 331 people with AAV across 20 countries, including Australia.
Participants were randomly assigned to receive either Tavneos or prednisone, a conventional anti-inflammatory medication, in addition to standard background therapies.
The results showed that a significantly greater proportion of Tavneos-treated patients achieved and sustained disease remission after about a year of treatment, compared with those given prednisone. Moreover, in patients with severe kidney impairment, Tavneos led to significantly greater improvements in kidney function than prednisone.
“This long-awaited new class of medication represents an important advancement for many patients living with AAV,” said Daman Langguth, MD, head of immunology at Sullivan Nicolaides Pathology and clinical immunologist at Wesley Hospital, in Brisbane, Australia.
“We are confident that this novel therapy will provide more options to help control the disease, extend remission and meet major unmet medical needs in the treatment of AAV,” Langguth added.