Pfizer's quest to gain an approval for a potential new blockbuster for rheumatoid arthritis has run into a speed bump at the FDA. Following a lopsided expert panel vote in its favor back in May, Pfizer CEO Ian Read told analysts on Tuesday that the agency is looking for some additional data analysis before it can come up with a formal decision on marketing the JAK inhibitor. And that new assignment will likely force a delay beyond the Aug. 23 PDUFA deadline.
It's hard to overestimate tofacitinib's importance to Pfizer ($PFE). After a long and miserable run in the clinic, in which the pharma giant proved unable to deliver major new drugs as the patent expiration on Lipitor loomed, the RA therapy is one of a small group of late-stage blockbuster contenders. The recent announcement that the Alzheimer's drug bapineuzumab failed the first of four late-stage studies has added considerable gloom about its prospects.
Pfizer, though, did have another page to add to its R&D book on the drug. In a two-year study comparing tofacitinib to the old standard methotrexate, the experimental drug arm showed fewer signs and symptoms as well as structural damage than the methotrexate arm. That top-line analysis won't be part of the package that the FDA will use in its review, but it could help Pfizer make its case to payers, who showed signs of increased skepticism about the drug's efficacy after members of the panel as well as the FDA review raised questions about whether the data package actually proves superior performance in reducing structural damage.
A final read on just how big an impact the new data will have on payers is likely going to have to wait, though, until the data is reviewed in detail at an upcoming medical conference.
Several analysts have tapped tofacitinib as a likely blockbuster worth more than a billion dollars a year in sales. But some payer surveys have detected that the FDA's concerns about Pfizer's efficacy data is persuading quite a lineup to decide to reimburse the drug only after a patient has failed two other therapies. And every time a payer puts a drugmaker back of the line, revenue drops.
- here's the press release on the data
- get the Dow Jones report
- read the AP story