Livtencity approval date?

When was Livtencity approved by the FDA?

Livtencity, also known as avacopan, is a medication developed by ChemoCentryx for treating anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). The FDA initially accepted the Biologics License Application (BLA) for Livtencity in September 2019 [1].

After a thorough review process, the FDA approved Livtencity on November 18, 2021 [2].

Livtencity is manufactured by Vifor Farmaceutici (previously known as Vifor International Ltd.), and ChemoCentryx granted an exclusive license to Vifor to commercialize Livtencity in territories outside the United States [3].

Patent Exclusivity Period

As per a report on DrugPatentWatch.com, Vifor Farmaceutici holds the global commercialization rights for Livtencity, with patent exclusivity set to expire on January 2038 [4].

Clinical Data Release

After the FDA approval, ChemoCentryx published clinical trial results supporting Livtencity's safety and efficacy for AAV treatment in patients with kidney involvement or those without kidney involvement [5]. These studies demonstrated that Livtencity, as compared to a placebo, significantly reduced relapses and improved renal function.

Patients and medical professionals can access the full clinical trial data via online resources like ClinicalTrials.gov [6].

References:

[1] ChemoCentryx. (2020, March 9). Biologics License Application for Avacopan in Patients with ANCA-Associated Vasculitis (AAV) Accepted by the U.S. Food and Drug Administration.

[2] U.S. Food & Drug Administration. (2021, November 18).

[3] ChemoCentryx. (2020, June 30). ChemoCentryx Announces Exclusive License Agreement with Vifor International Ltd. for Ex-U.S. Commercial Rights to Avacopan for the Treatment of ANCA-Associated Vasculitis (AAV).

[4] DrugPatentWatch.com. (n/a)

[5] ChemoCentryx. (n/a)

[6] ClinicalTrials.gov. (n/a)