Drugs giant wins approval in China for blood disorder treatment

Drugs pricing issues highlighted

Astrazeneca, the Anglo-Swedish pharmaceutical group, confirmed a treatment for anaemia has been approved for widespread use in China.

It said its partner, FibroGen (China) Medical Technology Development, has received marketing authorisation for roxadustat for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients.

This approval, granted by the National Medical Products Administration, is primarily supported by a Phase III trial in NDD-CKD patients with anaemia, in which roxadustat demonstrated a statistically-significant improvement in haemoglobin levels from baseline averaged over weeks seven to nine of treatment, with a mean change of 1.9 g/dL compared to -0.4 g/dL with a placebo.

This marketing authorisation follows the approval of roxadustat in China in December 2018 for anaemia in CKD patients who are on dialysis. AstraZeneca and FibroGen China expect to launch roxadustat in China during the second half of 2019.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “With this approval for roxadustat in China, we are now able to provide this first-in-class medicine to all patients living with chronic kidney disease who experience anaemia, regardless of whether they require dialysis.

“This is a significant milestone and we look forward to bringing the medicine to patients later this year.”

Anaemia caused by CKD is associated with cardiovascular disease, hospitalisation, cognitive impairment and reduced quality of life, and has been shown consistently to increase the risk of death in patients with CKD. Anaemia becomes increasingly common in patients with CKD as their disease progresses.

Roxadustat is a first-in-class, orally-administered small-molecule currently approved in China for the treatment of patients with anaemia from CKD on dialysis and not on dialysis.

AstraZeneca and FibroGen China are collaborating on the development and commercialisation of roxadustat in China.

FibroGen China, based in Beijing, is a wholly-owned subsidiary of FibroGen Inc that sponsored the development and registration of roxadustat.

FibroGen China conducted the China Phase III clinical trials and submitted the new drug application for registration of roxadustat to the Chinese regulatory authorities.

Following this approval, AstraZeneca will manage commercialisation activities in China, and FibroGen China will manage commercial manufacturing and medical affairs, as well as continued clinical development and regulatory affairs.

Anaemia commonly develops in association with CKD and is linked to significant morbidity and mortality in both the dialysis and non-dialysis populations.

CKD affects an estimated 120 million patients in China.

Although CKD may occur at any age, it is more common in ageing populations, and its prevalence is increasing.

CKD can be both a cause and a consequence of cardiovascular disease and is a critical healthcare issue. There is no treatment available that is curative or has the ability to stop kidney deterioration.

Astrazeneca employs around 4,700 people in the North West on sites at Macclesfield and Alderley Park in Cheshire and Speke on Merseyside.

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