Roche, a world leader in biotechnology, has submitted a Biological License Application (BLA) with the US Food and Drug Administration (FDA) to market CERA for the treatment of anaemia associated with chronic kidney disease (CKD) including patients on dialysis and not on dialysis, a company release said.

CERA, an innovative investigational anti-anaemia agent, is the first and only continuous erythropoietin receptor activator. This means that the activity of CERA at the receptor sites involved in stimulating red blood cell production is different from that observed with traditional epoetins. This distinct molecular interaction is believed to have a role in providing targeted, stable and sustained control of anaemia. CERA is the only anti-anaemia treatment to have been studied with long dosing intervals, up to once every four weeks, for its initial filing, stated a release.

"The US filing for CERA is the next step along the path to making this important therapy available," Eduard Holdener, Global Head Pharmaceutical Development, Roche said adding, "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."

The BLA submission is based on the largest clinical programme ever undertaken for a drug treating renal anaemia. It included six Phase III trials conducted in 29 countries and involved 2,400 patients. The studies investigated the efficacy of both intravenous and subcutaneous CERA administered up to once every four weeks.

In last December, the four maintenance studies from Phase III were successfully completed and very recently Roche completed the last two studies to treat (correct) anaemia. The studies met their primary endpoints and showed that both intravenous and subcutaneous CERA, when given at extended dosing intervals, were effective in correcting anaemia according to best practice guidelines, and in maintaining Hb levels following correction. Overall, the safety profile was characteristic of the population under study.