AstraZeneca Acquires FDA Priority Review Voucher for $95 Million, Likely to Expedite Roxadustat NDA

Today, AstraZeneca announced the acquisition of an FDA Priority Review Voucher from the Swedish company Sobi for $95 million. The Priority Review Voucher can shorten the approval timeline for new drug applications from 10 months to 6 months, thereby significantly accelerating the market launch of new drugs.

Which application will AstraZeneca advance using this Priority Review Voucher? Industry analysts suggest that AstraZeneca may leverage it to support the U.S. marketing application for its anemia drug roxadustat. Roxadustat was jointly developed by AstraZeneca and FibroGen, a partner of WuXi AppTec.

Renal anemia is one of the major complications during the decompensated phase of renal function in chronic kidney disease (CKD). CKD affects more than 200 million people worldwide, with approximately 120 million patients in China, among whom over 400,000 require dialysis.

Roxadustat is a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that can be conveniently administered orally. Hypoxia-inducible factor (HIF) not only increases the expression of erythropoietin (EPO), but also enhances the expression of EPO receptors and promotes the expression of proteins involved in iron absorption and circulation. Roxadustat inhibits prolyl hydroxylase (PH) by mimicking one of its substrates, α-ketoglutarate, thereby modulating the role of PH in maintaining the balance between HIF synthesis and degradation, ultimately correcting anemia. Roxadustat provides a new therapeutic option for patients with anemia associated with chronic kidney disease (CKD).

▲ Molecular structure of roxadustat (Image source: Meodipt [Public domain])

In the development of new drugs for treating renal anemia, Bayer’s molidustat and GlaxoSmithKline’s (GSK) daprodustat have already submitted new drug applications in Japan. Roxadustat was first approved for marketing in China last December for the treatment of dialysis-dependent chronic kidney disease (CKD)-related anemia. Today, roxadustat received further approval in China for an expanded indication to treat CKD-related anemia in non-dialysis-dependent patients. AstraZeneca is expected to submit a new drug application for roxadustat to the U.S. Food and Drug Administration (FDA) this October.

Some analysts also believe that AstraZeneca may use this priority review voucher to accelerate the marketing application for trastuzumab deruxtecan, an innovative HER2-targeting antibody-drug conjugate. Regardless of where AstraZeneca applies this priority review voucher, we hope it will fully serve its purpose of shortening the review timeline, thereby making new therapies available to patients sooner.

References:

[1] AstraZeneca agrees to buy US FDA Priority Review Voucher from Sobi. Retrieved Aug. 22, 2019, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/astrazeneca-agrees-to-buy-us-fda-priority-review-voucher-from-sobi-22082019.html

[2] Astra could use a voucher to cement roxadustat’s head start. Retrieved Aug. 22, 2019, from https://www.evaluate.com/vantage/articles/news/astra-could-use-voucher-cement-roxadustats-head-start

[3] China becomes the first country to approve roxadustat for all chronic kidney disease patients with anaemia. Retrieved Aug. 22, 2019, from https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/roxadustat-approved-in-china-for-the-treatment-of-anaemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease-22082019.html

[4] China’s First Launch! First-in-Class New Drug Roxadustat Officially Approved in China. Retrieved Aug. 22, 2019, from https://mp.weixin.qq.com/s/Tn6mqy9AEUlF_7ylmSp7ew

[5] Flash | GSK Submits First New Drug Application in Japan for the Treatment of Renal Anemia. Retrieved Aug. 22, 2019, from https://mp.weixin.qq.com/s/c9eqw_mvEJyq64TTUQbJlw

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