After 8 OS deaths TGA reviews drug

The TGA is officially reviewing the benefits and risks of a $32.8 million drug that has overseas regulators already looking to remove it from their markets following eight deaths and allegations trial results were manipulated.

Tavneos, used to treat the rare autoimmune condition antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, earned $32.8 million in pre-rebate R/PBS reimbursements for the financial year 2025-26, providing 3,875 services. It was listed less than two years ago, and in Australia is sponsored by CSL Seqirus, which obtained the rights when it bought Vifor. It was developed by ChemoCentryx, which was acquired by Amgen in 2022.

"The TGA is reviewing new information that has raised concerns regarding the integrity and reliability of the clinical trial data that supported the approval of Tavneos in Australia," the Department stated on its website.