AstraZeneca: China formulated anaemia drug on fast-track, but timeframes vague

By Dan Stanton

- Last updated on GMT

AZ talks fast-track in China. Image: iStock/IakovKalinin
AZ talks fast-track in China. Image: iStock/IakovKalinin

Related tags Epidermal growth factor receptor

AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.

The Phase III candidate roxadustat is a potential therapy for anaemia associated with chronic kidney disease being developed by Pharma Giant AstraZeneca and San Francisco-based firm FibroGen.

The hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is expected to be submitted for regulatory approval in the US in 2018, but is one of three products being fast-tracked in China, the company said, due to its formulation and local demand.

“The key thing for roxadustat is it's actually treated as a local product,”​ said Luke Miels, EVP of Global Product and Portfolio Strategy at the Anglo-Swedish Pharma Giant.

The drug is produced using locally-sourced materials, he told investors during a financial conference call yesterday, and “it's actually a different formulation than the global supply.”

This, along with China’s growing demand for medicines to combat rising rates of kidney disease, has meant roxadustat is “part of a new process called the green-pass,”​ similar to the US FDA’s rolling review​ fast-track stream, CEO Pascal Soriot added.

But despite this programme, Chinese regulators are still vague on setting out precise timeframes, Soriot continued.

“They have a lot of reasons to fast track this project, but it's not very codified, and so it's hard to predict how long it will take.”

Fibrogen and AZ are looking to file a submission in China this year.

On top of rozadustat, the firm said it has an innovative rheumatoid arthritis biologic in a fast-track programme developed through its collaboration with WuXi Apptech​, and an epidermal growth factor receptor (EGFR) inhibitor also

Along with stricter rules on quality, China has expanded its fast-track policy​ recently, in an attempt to expedite review of locally-made and high-demand pharmaceutical products.

For the full year 2015, AstraZeneca reported a 12% year-on-year growth to $5.8bn in product sales in emerging markets, with China growing by 15%.

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