Roche files application for Cera kidney treatment

Roche has announced that it has submitted a marketing application to the US Food and Drug Administration for the use of Cera as a treatment for renal anaemia.

The company said that the application is based on a phase III trial programme that included both dialysis and non-dialysis patients with chronic kidney disease (CKD) where it proved to be an effective treatment.

“The US filing for Cera is the next step along the path to making this important therapy available,” said Eduard Holdener, global head of pharmaceutical development at Roche.

“One of the primary endpoints we investigated was haemoglobin response and levels over time as we know that physicians find it challenging to keep patients’ haemoglobin in a recommended target range despite their best efforts. We believe Cera’s clinical profile is able to address this issue.”

There are more than 850,000 patients in America suffering with CKD either receiving dialysis or not, according to Roche.

The trials of the treatment involved 2,400 people across 29 countries worldwide and evaluated intravenous and subcutaneous use of Cera once every four weeks. Both were found to be effective in correcting anaemia.

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