27th May 2016 11:44
LONDON (Alliance News) - Drugmaker AstraZeneca PLC on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion on the company's saxa/dapa tablets for the treatment of type-2 diabetes.
The company said the regulator had recommended the approval of the drug in Europe and the opinion will now be reviewed by the European Commission.
Earlier in the day, AstraZeneca said the US Food & Drug Administration has issued a complete response letter on the new drug application made for sodium zirconium cyclosilicate, while also saying it secured good results from its Faslodex trials.
AstraZeneca said its faslodex drug met its primary endpoint for treating advanced breast cancer. The company said the drug met its target of extended progression-free survival.
Sean Bohen, executive vice president for global medicines development and chief medical officer at AstraZeneca, said the results from the trial bring AstraZeneca closer to offering more and earlier treatment options for post-menopausal women suffering with breast cancer.
Elsewhere, sodium zirconium cyclosilicate is an investigational medicine being developed by ZS Pharma, a subsidiary of AstraZeneca, for the treatment of hyperkalaemia, or high potassium levels in the blood.
The letter from the US FDA refers to observations made during a pre-approval manufacturing inspection, AstraZeneca said, and acknowledges recently submitted data which has yet to be reviewed by the US regulator.
AstraZeneca said it and ZS Pharma are reviewing the content of the letter and will work with the US FDA to determine the next steps for the new drug application.
The response letter means the drug's launch will likely be delayed until 2017.
AstraZeneca shares were down 1.1% to 3,967.5 pence.
By Sam Unsted; [email protected]; @SamUAtAlliance
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