Takeda receives EU approval for Rienso

Takeda has been granted European regulatory approval for its drug Rienso to be marketed as a treatment for iron deficiency anaemia in adult patients with chronic kidney disease.

The intravenous iron therapy, which was developed in conjunction with AMAG Pharmaceuticals, has been ratified by the European Commission, following a recommendation earlier this year by the Committee for Medicinal Products for Human Use (CHMP).

Data from the pivotal phase III safety and efficacy studies involving more than 1,700 patients has demonstrated the drug's ability to significantly increase haemoglobin levels as compared to oral iron.

This new treatment option will be made available to clinicians in the near future.

Trevor Smith, head of commercial operations at Takeda in Europe and Canada, said: "The granting of European marketing authorisation for ferumoxytol marks an important milestone for Takeda in our ongoing commitment to the field of renal medicine."

Earlier this week, the company was granted a CHMP recommendation for Revestive, its new treatment for short bowel syndrome.