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

An FDA advisory committee recommends against accelerated approval for olaparib, potentially justifying a lower bid from Pfizer.

Jun 25, 2014 at 9:35PM

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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4 in 5 Americans Are Ignoring Buffett's Warning

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Jun 12, 2015 at 5:01PM

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