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Data Raise Hopes Of Accelerated Approval For Hansa's Kidney Transplant-Enabling Imlifidase

 
• By John Davis

Kidney transplantation might be possible in difficult-to-graft highly sensitized patients using Hansa Medical's IgG-cleaving product, imlifidase. The high unmet need for such a product might usher in a Phase II data-based approval.  

Kidney

The potential of Hansa Medical AB's lead product, imlifidase, to enable kidney transplantation in highly sensitized patients, as shown in positive final top-line results from two Phase II clinical studies in 35 patients, has led the company to start planning for possible approval filings in the next several quarters, and the building of commercialization infrastructure in the US and elsewhere.

Hansa Medical is seeking end-of-Phase II meetings with regulators in the EU and US with a view to pursuing accelerated approval/priority review for imlifidase in kidney transplantation in highly HLA sensitized patients, an indication

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