New domestically developed drug for anemia approved

The world’s first oral drug for patients with anemia due to chronic kidney disease has been approved in China. 

The domestically-developed medicine allows Chinese patients to benefit from the new therapy earlier than patients in the United States and Europe, while also reflecting the development of China’s pharmaceutical innovation.

The National Medical Products Administration announced the approval of roxadustat for the treatment of patients with anemia in chronic kidney disease who are dialysis-dependent on Tuesday.

Roxadustat, whose phase-three clinical trial was led by Dr Chen Nan from Shanghai’s Ruijin Hospital, is co-developed by FibroGen China and AstraZeneca China. The two companies will launch roxadustat in China in the second half of 2019.

According to Chen Nan, anaemia is a common complication of chronic kidney disease, which currently affects some 120 million Chinese. About one third with early stage of kidney disease have anemia, and that percentage grows along with the deterioration of kidney function. About half of patients in mid-stage of kidney disease suffer anemia and almost all will develop anemia if kidney condition develops into uremia.

Anemia due to chronic kidney disease can bring damage to the entire body and other organs, as well as speeding up the worsening of kidney disease and increasing the risk of dialysis, cardiovascular disease and mortality, doctors said.

However, there has been no innovative therapy targeting the problem in the past 30 years — less than 60 percent of patients with such anemia have their problem under control.

“Roxadustat can not only bring an effective and well tolerated new therapy to Chinese patients with anemia due to chronic kidney disease, but also trigger a revolution in the treatment of anemia in kidney disease,” Chen said. “Development of the drug gives a chance for the Chinese medical field relating to kidney disease to take the leading place in this aspect.”