Policy & Regulation
CSL Vifor and Fresenius Kabi announce approval of iron deficiency treatment Ferinject by China's National Medical Products Administration
28 November 2022 -

Pharmaceutical company CSL Vifor and healthcare firm Fresenius Kabi announced on Monday that China's National Medical Products Administration (NMPA) has approved Ferinject, a preparation for intravenous iron therapy for the treatment of iron deficiency in adult patients for whom oral iron preparations are ineffective, oral iron preparations cannot be used or for whom there is a clinical need to rapidly deliver iron.

Ferinject marketing authorisation in China is based on positive clinical results from the phase-III trial VIT-IRON-2011-004, an open label, randomised multicentre study that demonstrated Ferinject as an effective and well-tolerated alternative to iron sucrose for the treatment of iron deficiency anemia that can provide an improved hemoglobin response and correction of iron deficiency in Chinese patients.

The companies stated that Ferinject has now received marketing authorization in 85 countries. Ferinject is anticipated to begin marketing in the first half of 2023, with National Reimbursement Drug List (NRDL) listing expected in January 2024.

According to CSL Vifor and Fresenius Kabi, this approval of Ferinject may also enable a more effective implementation of Patient Blood Management (PBM) in Chinese hospitals, where it is estimated that three to four million patients undergo elective surgery annually.

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