Roche says data points to efficacy of anemia drug

[okarol]

Roche says data points to efficacy of anemia drug

13th April 2007
By Victoria Harrison

Roche has said that new data regarding its drug Mircera has highlighted its efficacy and safety for use in renal anemia associated with chronic kidney disease.

According to these analyses, Mircera corrected and maintained hemoglobin (Hb) levels in patients with chronic kidney disease (CKD). The drug also maintained Hb levels in dialysis patients, regardless of congestive heart failure status and exhibited a safety profile that is consistent with that of standard treatments such as erythropoiesis stimulating agents.

"The goal in treating renal anemia is to safely maintain target hemoglobin levels," said Steven Fishbane, associate director of Nephrology at Winthrop University Hospital. "These data analyses clearly demonstrate that Mircera corrected low hemoglobin levels, and maintained target hemoglobin levels with the added convenience of up to once-monthly dosing."

The research was an overview of six global studies that compared Mircera with epoetin alfa or beta and with darbepoetin alfa. This overview showed that the efficacy of Mircera was equivalent to that of the comparator agents, but required less frequent administration.

Roche filed applications with the regulatory authorities in the US and in the European Union in April 2006 seeking approval for the use of the treatment for anemia associated with CKD in patients on dialysis and not on dialysis.

http://www.pharmaceutical-business-review.com/article_news.asp?guid=834E3A2C-4206-4AAA-8E36-CCC35339322F

[kitkatz]

How long will it take to trickle down to the patients?