AstraZeneca PLC AZN announced that its partner FibroGen China has received the second marketing approval for roxadustat in China. This time, the Chinese regulatory authority has granted a nod to roxadustat for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients.
FibroGen China is a wholly-owned subsidiary of FibroGen, Inc. FGEN.
China's National Medical Products Administration (NMPA) granted the approval based on data from the phase III study, which evaluated roxadustat in the above-mentioned patient population. In the study, roxadustat demonstrated a statistically significant improvement in haemoglobin levels from baseline averaged over week seven to nine of treatment.
Notably, last December, the Chinese regulatory agency approved roxadustat for treating anaemia in CKD patients, who are dialysis-dependent.
Following this label expansion nod, China became the first country to approve roxadustat for all CKD patients, who experience anaemia whether on dialysis or not. Both AstraZeneca and FibroGen China plan to launch roxadustat later this year. The former will take care of the commercialization activities in China while the latter will look after manufacturing, clinical development and other regulatory affairs.
Roxadustat, a first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor, is being jointly developed by AstraZeneca and FibroGen for treating anaemia in CKD patients.
Meanwhile, both companies are planning to file a new drug application (NDA) to the FDA for getting roxadustat approved in the United States in the second half of 2019.
Shares of AstraZeneca have rallied 19.5% so far this year against the industry’s decrease of 2.2%.
In a separate press release, the company announced that it has agreed to buy an FDA priority review voucher from a subsidiary of Swedish Orphan Biovitrum AB (Sobi) for $95 million in cash.
The transaction is subject to close under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
With the help of this priority voucher, AstraZeneca can ask for a priority review from the FDA for any candidate of its choice to reduce the review time and get an expedited approval.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large-cap pharma sector include Merck & Co., Inc. MRK and Eli Lilly and Company LLY, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have moved 3.2% north for 2019 and 1.1% for 2020 over the past 60 days. The stock has gained 13.7% year to date.
Eli Lilly’s earnings estimates have been revised 1.1% upward for 2019 and 0.5% for 2020 over the past 60 days.
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