The European Medicines Agency (EMA) has recommended revoking the marketing authorization for Tavneos (avacopan, ChemoCentryx) in the European Union because its benefits are no longer proven to outweigh its risks.
Tavneos is used to treat adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory conditions of the blood vessels.
A review of the drug was initiated at the request of the European Commission following new information questioning the data integrity of the ADVOCATE study, which was used as evidence to support the former EU marketing authorization.
Due to “breaches of good clinical practice,” the EMA said that data from this pivotal trial could no longer be relied upon to demonstrate the medicine’s efficacy.
Tavneos is used as part of a combined treatment that also includes rituximab or cyclophosphamide. Its active substance is avacopan, a complement 5a receptor blocker that aims to reduce blood vessel inflammation.
In the ADVOCATE study, 331 patients with GPA or MPA were given a 52-week course of avacopan or placebo, together with a 20-week course of corticosteroids, both in addition to standard treatment. Based on data from the study, avacopan was found to be at least as effective as the 20-week course of high-dose corticosteroids in inducing remission in patients with GPA or MPA, and led to better long-term remission rates than the comparator.
However, after subsequent review of the available data and new information on how the study data were handled, the EMA concluded that it was conducted in breach of good clinical practice principles. It highlighted that study data provided at the time of the assessment of the marketing authorization application were found to be “incorrect and misleading” and could no longer be relied upon for demonstrating the drug’s effectiveness.
The EMA recommended that no new patients should be started on Tavneos and that those currently receiving it should be switched to suitable alternatives.
As Tavneos is associated with an increased risk for drug-induced liver injury and vanishing bile duct syndrome (VBDS) — a rare condition where the small bile ducts inside the liver are gradually damaged and disappear over time — the EMA advised that liver function should be closely monitored until treatment is permanently stopped. If VBDS is suspected, Tavneos should be discontinued immediately.
The EMA’s opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. If the recommendation is confirmed by the European Commission, Tavneos will no longer be authorized in the EU.
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