InflaRx seeks to fill void left by Amgen’s Tavneos in Europe

What’s new: Jena, Germany-based InflaRx made the announcement following the decision of the European Medicines Agency’s CHMP regulatory committee, which last week recommended Tavneos’s marketing authorisation in the EU should be revoked.

Why it matters: InflaRx has two potential competitor drugs – it says its anti-C5a antibody vilobelimab is “phase 3 ready” in AAV, while izicopan is being prepared for phase 2.

Zoom in: In the Friday announcement, the CHMP said the benefits of Tavneos could not be proven to outweigh its risks in active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare forms of AAV.

• The FDA has also been monitoring the safety of Tavneos and found 76 cases of drug-induced liver injury with reasonable evidence of a causal association with avacopan use. A total of 74 cases reported a serious outcome, including 54 hospitalisations and eight deaths.

The backstory: The EMA began its review on 30 January after the FDA requested Amgen to voluntarily pull the drug from the market, based on a reassessment of the trial conduct and the drug’s risk-benefit profile – a request that Amgen refused.

• This week the row has intensified, and not just because of the CHMP’s decision – the New England Journal of Medicine on Monday retracted an article outlining pivotal data from the trial on the request of two authors.
• The FDA’s investigation into Tavneos found that without the authors’ knowledge, results for nine patients were readjudicated after database lock and trial unblinding.

What they’re saying: In its statement, InflaRx said it had completed two Phase 2 vilobelimab studies in the U.S. and Europe. BDB-001, a vilobelimab cell line-produced antibody, has completed Phase 2 development and is being evaluated by InflaRx’s collaborator, Staidson BioPharmaceuticals Co., Ltd. (Staidson), in a Phase 3 trial in AAV in China.

What’s next: InflaRx can’t give timelines for development for AAV for vilobelimab, which is approved under exceptional circumstances under the brand name Gohibic in Europe for SARS-CoV-2-induced acute respiratory distress syndrome.

• Izicopan is due to begin Phase 2 development in AAV around the end of 2026 or the beginning of 2027.

What other options are available? Rituximab can be used to treat AAV, sometimes in combination with the chemotherapy cyclophosphamide. Other options include azathioprine, methotrexate, and glucocorticoids.

What did Amgen say? In a statement on Tavneos, last updated at the beginning of June, Amgen said it “remains confident in the overall risk-benefit profile of Tavneos”.