Pfizer lays out its pivotal case for oral RA pill against blockbuster Humira

Pfizer ($PFE) today laid out data from a slate of studies on its rheumatoid arthritis pill tofacitinib--a potential blockbuster--building a case that the oral drug is comparable to Humira. Investigators for the pharma giant were careful to note the studies weren't designed to provide a true head-to-head comparison. But they didn't shy away from emphasizing the efficacy data for both treatments looked similar while no new safety issues were divined in the pivotal program. And a spokesperson noted Pfizer is on track to file for approval.

"Pfizer believes the risk-benefit profile supports regulatory submission for both the 5 and 10 mg dose," Pfizer spokesperson Victoria Davis told Bloomberg. "We are looking forward to filing in the U.S., EU and Japan by the end of the year."

Before any approvals are handed out, however, Pfizer faces some serious grilling about the safety data. There were 12 deaths among the 3,030 patients taking the drug, compared with one death in the Humira arm of 204, according to the Bloomberg report. However, deaths based on the amount of time a patient spent taking a drug were similar. But infection rates were higher in the tofacitinib group.

Reuters focused on one 12-month study that compared a 5- and 10-mg dose of tofacitinib against Humira and a separate placebo arm. There the efficacy was similar, but side effects were slightly higher in the tofacitinib arm.

If the oral JAK inhibitor holds up under regulatory scrutiny, Pfizer could be allowed to compete against the injectables that dominate the field, offering an entry that could net up to $2 billion in a few years. An approval would also add to a string of upbeat pipeline advances for Pfizer, which has been castigated for a series of clinical pratfalls in the last few years.

- here's the Pfizer press release
- get the Reuters story
- check out the Bloomberg report