US biotechnology company Amgen (NASDAQ: AMGN) has announced that it has received market approval in China for its drug Tavneos (avacopan). The National Medical Products Administration (NMPA) has approved Tavneos for use as adjuvant therapy in adults with severe and active anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis, specifically granulomatous polyangitis or microscopic polyangitis, under standard treatment containing glucocorticoids.
Avacopan’s Global Approvals and Its First-In-Class Status
Avacopan, a first-in-class drug for the treatment of ANCA-associated vasculitis, was approved in the US in October 2021 as adjuvant therapy for active severe ANCA-associated vasculitis (MPA and GPA) in adults. The drug is used in combination with standard treatment regimens, including glucocorticoids, which cannot be eliminated by avacopan. Since then, it has gained marketing approval in several countries, including Canada, Australia, the UK, Germany, UAE, Japan, and South Korea.
Amgen’s Licensing Deal with CSL Vifor for Commercialization Rights
Amgen has entered into a licensing agreement with CSL Vifor, granting commercialization rights to the drug in Asia and Latin America, including mainland China. This deal expands the reach of Tavneos (avacopan) in key regional markets, potentially benefiting patients with ANCA-associated vasculitis across these regions.- Flcube.com
