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AstraZeneca plc Fails to Convince FDA Committee of Olaparib's Merit. Pfizer Next?

AstraZeneca (NYSE: AZN  ) failed to convince a Food and Drug Administration advisory committee that phase 2 data testing olaparib in ovarian cancer patients was good enough to award the drug an accelerated approval.

It wasn't even close.

The final vote came in at 11 to 2 recommending the FDA not approve the drug. The FDA doesn't have to follow the panel's advice, but given the negative tone of the briefing documents the agency sent to the committee before the meeting, it seems highly unlikely the agency would go against the negative recommendation.

In the grand scheme of things, not getting approved now isn't that big of a deal for AstraZeneca. If olaparib was given an accelerated approval, it would be dependent on the ongoing phase 3 trial coming up positive. If that happens, olaparib should get a standard approval. The phase 3 study is expected to be completed by the end of next year.

Before then, Pfizer could make another bid for the company. AstraZeneca cited the potential of olaparib as one of the reasons Pfizer's bid was too low. That argument is somewhat weakened by the negative vote and inevitable rejection even though the long-term potential is still yet to be decided.

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DocumentId: 3008638, ~/Articles/ArticleHandler.aspx, 8/28/2015 3:38:46 PM

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Brian Orelli

Dr. Orelli is a Senior Biotech Specialist. He has written about biotech, pharmaceutical, and medical device companies for The Motley Fool since 2007.

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8/28/2015 3:22 PM
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AstraZeneca plc (A… CAPS Rating: ****