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Home Industry News AstraZeneca informed of FDA gastric ulcer review

AstraZeneca informed of FDA gastric ulcer review

20th October 2008

AstraZeneca has announced that it and Pozen, its co-development partners for the investigational compound PN 400, have been informed by the US Food and Drug Administration (FDA) that the body is conducting an internal review of endoscopic gastric ulcers as a primary endpoint in studies.

The administration has not made clear when the internal review will be completed, but an FDA internal meeting has been planned to review this topic area during the first three months of next year.

Continuing, AstraZeneca states at the completion of the special protocol assessment (SOA) for the PN 200 compound, Pozen reached an accord with the FDA regarding the design of its pivotal trials for the drug, which specified the primary endpoint as the reduction in gastric ulcers versus enteric coated naproxen.

The development programme for PN 200 also applied to PN 400, the FDA told AstraZeneca.

“It is unclear at this time what impact, if any, the FDA’s internal review will have. However, the PN 400 clinical programme will continue to progress under the SPA agreed development plan with the FDA,” the company concludes.

AstraZeneca recently announced the FDA had approved its Seroquel drug for treatment of bipolar depression and mania in the USA.

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