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AstraZeneca issues updates on roxadustat and Tagrisso
21st Dec 2020 08:03
(Sharecast News) - Pharmaceutical giant AstraZeneca issued updates on both roxadustat and Tagrisso on Monday, with one drug facing a delay to its application and the other being granted approval in the US.
AstraZeneca said the US Food and Drug Administration has requested further clarifying analyses of clinical data, to complete its review of its new drug application for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for patients with anaemia of chronic kidney disease.
The FTSE 250-listed firm said the application, which now depends on it submitting additional clarifying analyses to assist with the completion of labelling discussions, remained under regulatory review, with the FDA having set a new action date of 20 March 2021.
Moving on to Tagrisso, AZN said the drug had been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after tumour resection with curative intent.
The approval was granted under the FDA's real-time oncology review pilot program and was based on results from the ADAURA Phase III trial, where Tagrisso demonstrated a "statistically significant and clinically meaningful improvement" in disease-free survival.
As of 0840 GMT, AstraZeneca shares were up 0.31% at 7,531.0p.
AstraZeneca said the US Food and Drug Administration has requested further clarifying analyses of clinical data, to complete its review of its new drug application for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for patients with anaemia of chronic kidney disease.
The FTSE 250-listed firm said the application, which now depends on it submitting additional clarifying analyses to assist with the completion of labelling discussions, remained under regulatory review, with the FDA having set a new action date of 20 March 2021.
Moving on to Tagrisso, AZN said the drug had been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after tumour resection with curative intent.
The approval was granted under the FDA's real-time oncology review pilot program and was based on results from the ADAURA Phase III trial, where Tagrisso demonstrated a "statistically significant and clinically meaningful improvement" in disease-free survival.
As of 0840 GMT, AstraZeneca shares were up 0.31% at 7,531.0p.