FDA clears Affymax' anaemia drug Omontys

The US FDA has approved Omontys, a new treatment developed by Affymax for anaemia in patients on dialysis.

Omontys (peginesatide) is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells, and is the first new drug to be approved for treating anaemia in chronic kidney disease patients since 2001.

It will be co-marketed in the US by Takeda Pharmaceutical, which filed for approval of the product in Europe last month, and is due for launch in the US within the next month.

The drug works by stimulating the bone marrow to produce more red blood cells, and is administered as a once-monthly injection, in contrast to the current generation of epoetin-based drugs which require more frequent dosing.

At the moment, chronic kidney disease patients on dialysis are treated with Amgen's Epogen (epoetin alfa), which requires dosing three times a week, or second-generation product Aranesp (darbepoetin alfa) which can be given either weekly or every two weeks.

Omontys could be a boon to healthcare payors such as Medicare, as well as providing more convenience to patients, as it could reduce the overall cost of managing dialysis patients by injecting some competition into the dialysis treatment sector.

Peginesatide may generate as much as $700m in peak sales by 2017, according to Ian Somaiya, an analyst at Piper Jaffray & Co, in an interview with Bloomberg.

Last year Epogen had US sales of just over $2bn, down from $2.5bn in 2010, while Aranesp added $2.3bn to Amgen's coffers, including a little under $1bn from the US market.

US approval was based on two clinical trials involving 1,608 patients with haemoglobin levels initially stabilised by epoetin therapy who were randomised to receive either Omontys once monthly or to continue their current epoetin treatment.

The results showed Omontys was as safe and effective as epoetin in maintaining haemoglobin levels within the studies' pre-specified range of 10g to 12g per decilitre.