Pfizer put out word this morning that the FDA has opted to delay its application for tofacitinib for three months as it works through some additional analyses of data the Big Pharma has offered to support its NDA for the rheumatoid arthritis treatment. The drug giant ($PFE), which badly needs this approval to help repair its R&D rep after the monumental train wreck involving the Alzheimer's drug bapineuzumab, emphasized that regulators are not asking for any new trials--which of course would mean a much greater delay.
"The FDA determined that additional data analyses recently submitted by Pfizer constitute a major amendment to the application and will require additional time to review," the company noted this morning. That's in line with a comment that Pfizer CEO Ian Read made to analysts at the beginning of the month, as he signaled the agency's interest in fresh analysis. The new PDUFA date is November 21.
Postponement may play to Pfizer's advantage. There's been some serious skepticism whether Pfizer has demonstrated superior efficacy for tofacitinib over currently used drugs. Since it filed its regulatory package, though, the drug company's R&D wing has offered fresh evidence that the treatment can reduce structural damage for patients. Now it has more time to assemble its case for payers as regulators scan the data.
Pfizer boasts that it has submitted the largest dataset ever used to back an RA program.
- here's the press release
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As FDA pushes by decision date for Pfizer's tofacitinib, RA patients wish FDA would hurry up.
Input from @JohnCFierce
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