BRIEF—Hansa BioPharma secures first international approval in Australia

Swedish enzyme technology firm Hansa Biopharma announced that the Australian Therapeutic Goods Administration (TGA) has provisionally approved Idefirix (imlifidase) as desensitization treatment for highly sensitized patients prior to kidney transplantation from both living and deceased donors.

The provisional approval has a duration of two years and was based on data from Hansa’s Phase II studies that included highly sensitized patients who received a kidney from either a living (17%) or deceased donor (83%) following desensitization treatment with imlifidase.

Market access has now been secured in 12 European countries and approval in Australia is the first international approval

The pivotal US ConfIdeS trial for imlifidase in kidney transplantation is due to complete randomization this year to support a Food and Drug Administration (FDA) accelerated submission in 2024, said Hansa.

In line with the EMA’s conditional approval, full approval in Australia will require submission to the TGA of further safety and efficacy data from studies that are currently underway, the company noted.