With the European Union formally reversing its marketing authorization for rare disease med Tavneos last week, regulators from the bloc are laying out their concerns on the data backing the complement inhibitor in greater detail.
Tavneos, which is used in the two most common forms of the autoimmune disorder ANCA-associated vasculitis, was originally developed by ChemoCentryx, which itself was acquired by Amgen for $3.7 billion in 2022. Stateside, Amgen is fighting to keep Tavneos on the market after an FDA market withdrawal request earlier this year kicked off a regulatory back-and-forth over safety and data concerns tied to a ChemoCentryx-run study.
In Europe, meanwhile, Tavneos’ marketing rights fell under the purview of CSL Vifor.
CSL Vifor confirmed late last week that the European Commission had given the final word on Tavneos’ marketing status in the EU, adopting a June recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to revoke the drug’s commercial clearance.
Tavneos had boasted a 2022 go-ahead in Europe to treat the two forms of ANCA-associated vasculitis known as active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), as part of a combination with either Roche’s Rituxan (rituximab) or the chemotherapy cyclophosphamide.
