▎ WuXi AppTec content team editor On September 27, 2021, ChemoCentryx, Vifor Pharma, and Kissei Pharmaceutical jointly announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Tavneos (avacopan) to be marketed in Japan
Avacopan is an orally administered selective complement C5a receptor (C5aR) inhibitor for the treatment of two major anti-neutrophil cytoplasmic autoantibodies (ANCA)-related vasculitis: Microscopic polyangiitis (MPA) ) And granuloma with polyangiitis (GPA)
ANCA-associated vasculitis is a rare and serious autoimmune nephropathy with high unmet medical needs
The press release pointed out that this is the first time this C5aR inhibitor has been approved globally
It is currently undergoing review by the US FDA
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
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
Avacopan precisely blocks C5aR located on inflammatory cells such as neutrophils, prevents these cells from being activated by C5a, and reduces inflammatory damage
Image source: ChemoCentryx official website The approval is supported by the positive results of a pivotal Phase 3 trial
Data from 331 patients with polyangiitis and granuloma with polyangiitis showed that according to the Birmingham Vasculitis Activity Score (BVAS), the remission rate of the avacopan group was better than standard treatment at the 52nd week of treatment
▲At the 52nd week of treatment, the remission rate of the avacopan group was better than that of the standard treatment (picture source: reference ).
Specifically, at the 52nd week of treatment, 65.
7% of the patients in the avacopan group observed sustained remission.
The drug group was 54.
9% (non-inferiority P<0.
001; superiority P=0.
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)
ChemoCentryx is also developing avacopan for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and lupus nephritis (LN)
The FDA has granted avacopan an orphan drug designation for the treatment of ANCA-related vasculitis and C3 glomerulopathy
Schall, President and CEO of ChemoCentryx, said: “This marks the first time that a new drug discovered and developed by ChemoCentryx has been approved by regulatory agencies
We would like to thank Kissei and the Japanese Ministry of Health, Labour and Welfare for their time and great efforts to make This important milestone is made possible and is expected to bring relief to patients with significant unmet needs
"Reference:  VFMCRP announces approval for Tavneos® (avacopan) for the treatment of ANCA-associated vasculitis in Japan.
Retrieved September 27, 2021, from https:// en/ ChemoCentryx Announces Approval in Japan of Tavneos™ (Avacopan) for the Treatment of ANCA-Associated Vasculitis.
Retrieved September 27, 2021, from https:// 27/2303617/19219/en/ChemoCentryx-Announces-Approval-in-Japan-of-Tavneos-Avacopan-for-the-Treatment-of-ANCA-Associated-Vasculitis.
html Avacopan for the Treatment of ANCA-Associated Vasculitis.
New England Journal of Medicine, 384(21), e81.
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