Express U.S. FDA approves the first oral complement 5a receptor inhibitor

▎Editor of WuXi AppTec's content team On October 8, 2021, ChemoCentryx announced that the US FDA has approved the oral selective complement 5a (C5a) receptor inhibitor Tavneos (avacopan) to be marketed, combined with standard therapies, and two main adjuvant treatments Anti-neutrophil cytoplasmic autoantibodies (ANCA) related vasculitis: microscopic polyangiitis (MPA) and granuloma with polyangiitis (GPA)
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ANCA-associated vasculitis is a rare and serious autoimmune nephropathy with high unmet medical needs
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The press release pointed out that this is the first time the FDA has approved an ANCA-related vasculitis drug in ten years, and it is also the first oral complement C5a receptor inhibitor approved by the FDA
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 ANCA-associated vasculitis is a systemic disease in which excessive activation of the C5a complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels, which can cause organ damage and failure
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At present, the treatment of ANCA-related vasculitis includes non-specific immunosuppressants (cyclophosphamide or rituximab), combined with daily glucocorticoid long-term administration, which may lead to significant clinical risks, including death due to infection
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 Avacopan precisely blocks C5a receptors located on inflammatory cells such as neutrophils to prevent these cells from being activated by C5a and reduce inflammatory damage
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Image source: ChemoCentryx official website The approval is supported by positive results from a pivotal Phase 3 trial
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Data from 331 patients with polyangiitis and granuloma with polyangiitis showed that according to the Birmingham Vasculitis Activity Score (BVAS), at the 52nd week of treatment, the remission rate of the avacopan group was better than that of standard treatment
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▲At the 52nd week of treatment, the remission rate of the avacopan group was better than that of the standard treatment (picture source: reference [2]).
Specifically, at the 52nd week of treatment, 65.
7% of the patients in the avacopan group observed sustained remission.
The group was 54.
9% (non-inferiority P<0.
001; superiority P=0.
007)
.

 In terms of safety, 37.
3% of patients treated with avacopan and 39.
0% of patients treated with control drugs had serious adverse events (excluding worsening of vasculitis)
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 Dr.
Thomas J.
Schall, President and CEO of ChemoCentryx, said: "Today is an important milestone in ChemoCentryx's history, providing new hope for patients suffering from this debilitating and deadly disease
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We look forward to as soon as possible in the next few weeks.
Provide Tavneos to clinicians and patients
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"Reference: [1] ChemoCentryx Announces FDA Approval of Tavneos™ (avacopan) in ANCA-Associated Vasculitis.
Retrieved October 8, 2021, from https:// 2311086/19219/en/ChemoCentryx-Announces-FDA-Approval-of-Tavneos-avacopan-in-ANCA-Associated-Vasculitis.
html[2] Avacopan for the Treatment of ANCA-Associated Vasculitis.
(2021).
New England Journal of Medicine , 384(21),e81.
https://doi.
org/10.
1056/nejmc2104672 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.

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in the
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.

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