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AstraZeneca PLC on Thursday alongside US peer Merck & Co, announced that the US Food & Drug Administration will extend the Prescription Drug User Fee Act date by three months to allow further time for a full review of the supplementary new drug application of Lynparza in combination with abiraterone and prednisone or prednisolone.
The review is for Lynparza in combination for the treatment of metastatic castration-resistant prostate cancer.
Last month, EU’s Medicines Agency Committee for Medicinal Products for Human Use recommended to approve Lynparza in combination with abiraterone and prednisone or prednisolone in the EU for the treatment of the aforementioned cancer, for people who are not clinically indicate to undergo chemotherapy.
AstraZeneca shares were 0.6% lower at 11,328.00 pence each on Thursday morning in London.
By Tom Budszus, Alliance News reporter
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