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Home Industry News AstraZeneca submits sNDA for Symbicort

AstraZeneca submits sNDA for Symbicort

30th April 2008

AstraZeneca has submitted a supplemental New Drug Application (sNDA) for approval of its Symbicort inhalation treatment for patients with Chronic Obstructive Pulmonary Disease (COPD), it has been announced.

The company said the sNDA is based on two efficiency and safety trials of the drug on patients suffering with varying degrees of COPD, which found that it was “effective and well-tolerated for up to 12 months” among medium to very severe cases.

In particular, Symbicourt was well tolerated among patients compared to monoproducts budesonide, formoterol and placebo.

AstraZeneca chief medical officer Howard Hutchinson said: “Symbicourt is a combination maintenance treatment for patients with asthma that works rapidly to help improve lung function by reducing inflammation in the lining of the lung.”

He added that he was “confident” that the results of the two trials would support the company’s submission for a sNDA from the US Food and Drug Administration.

According to the World Health Organisation, an estimated 210 million people suffer from COPD worldwide.

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