20th Jan 2020 08:33
(Alliance News) - AstraZeneca PLC said Monday the US Food & Drug Administration accepted a supplemental new drug application for Lynparza and granted a priority review in the US for treatment of patients with prostate cancer.
AstraZeneca co-develops and co-commercialises Lynparza together with Merck & Co Inc.
The drugmaker said the priority review is based on results from the phase II PROfound trial, which showed that Lynparza "significantly reduced the risk of disease progression or death".
In a separate statement, AstraZeneca said Imfinzi and tremelimumab have been granted orphan drug designation in the US for the treatment of liver cancer.
The FDA gives the orphan drug designation to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
AstraZeneca shares were trading 0.4% lower in London at 7,845.00 pence each on Monday.
By Loreta Juodagalvyte; [email protected]
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