Nov 21 · Recommended for EU approval by CHMP for use “in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)”. Tavneos will be available as 10 mg hard capsules [16].
Oct 21 · FDA approves avacopan as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) [15]
May 21 · Positive opinion issued by advisory board after 10 experts voted that benefit-risk profile supports approval vs. 8 who voted against authorisation [14].
May 21 · US FDA released a briefing document ahead of an FDA Arthritis Advisory Committee meeting citing concerns regarding clinical data from the PIII trial of avacopan. Specifically, the noninferiority observation at the 26-week follow up period, e.g. at 52 weeks in pts on avacopan, the response rate was ~15% higher than with control in a subgroup taking rituximab background induction therapy. But the response rate was only 3% in a subgroup on cyclophosphamide, suggesting the possibility that it may only be effective in a population considered undertreated. The FDA panel will discuss these concerns, the context of use and the benefit-risk of avacopan for the treatment of AAV.[13]
Nov 20 · Filed in EU for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangitis (GPA) and microscopic polyangiitis (MPA)) [11].
Jul 20 · ChemoCentryx has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avacopan for the treatment of patients with ANCA-associated vasculitis [10].
Apr 20 · In its latest annual report, Vifor announces that following positive topline data for the avacopan pivotal PIII ADVOCATE trial announced in 2019, filing in Europe is expected in 2020 [9].
Mar 20 · Following on from advice received from the company, NICE has decided to suspend this appraisal from its current work programme [7].
Mar 20 · In its latest annual report, ChemoCentryx states that in the US, it is currently preparing an NDA for avacopan, which it plans to file with the FDA in mid-2020. The company will also support its international commercialisation partner Vifor and its Japanese sublicensee Kissei Pharmaceutical, Co., Ltd. in their regulatory approval applications. Vifor will commercialise avacopan in Europe [8]
Nov 19 · Company announced plans to make regulatory submissions for full marketing approval to both the EMA and FDA in 2020.[7]
Jan 19 · In their announcement of the EMA application withdrawal, Chemocentryx comment that they expect topline data from the ADVOCATE trial in Q4 2019 and expect to re-apply to both EMA and FDA in 2020 based on this data. With PRIME status, EU approval could take as little as 8 months from filing if there are no delays. [6]
Jan 19 · EMA filing withdrawn. The filing was for conditional authorisation, and at the time of withdrawal the CHMP was of the provisional opinion that the data provided by the company to that point were insufficient to show effectiveness. There were also concerns over the limited safety data and over the choice of starting materials used in manufacture. The Committee was therefore of the opinion that the company had not provided enough data to support the application. In reply, the company has stated that it intends to focus on future submission of a full marketing authorisation: this will be based on the results of the ongoing ADVOCATE study, which is larger and has a longer treatment duration [5].
Jan 18 · Filed in EU using centralised procedure. Is an orphan status drug in EU [4].
Jun 16 · EMA grants Priority Medicines (PRIME) designation to avacopan for treatment of ANCA-associated vasculitis [3].