After painting a poor safety profile, Pfizer and Eli Lilly are shooting for a new pain drug OK anyway
Months after analysts wrote off the NGF pain drug tanezumab as a perpetual loser, Pfizer and Eli Lilly have decided to push ahead and see if they can’t squeeze past the FDA with the low-dose version of this therapy.
Pfizer posted the news with their Q2 update on Monday, noting that they decided to go for it on the 2.5 mg dose after a sit-down with regulators and a careful review of the “totality” of the data. The 5 mg dose is being shelved.
But it’s going to be an uphill slog on this one.
In their pivotal trial, investigators reported a dose-dependent increase for the primary composite joint safety endpoint: 7.1% in the 5 mg arm, 3.8% in the 2.5 mg group and 1.8% for NSAIDs. Rapidly progressive osteoarthritis was the main concern, while “total joint replacement was 8% percent in the tanezumab 5 mg arm, 5.3% in the tanezumab 2.5 mg arm and 2.6% in the NSAIDs arm.”
With a doubling of the joint blowout rate in that 2.5 mg group, the drug makers may find a skeptical group of reviewers at the FDA. But regulators have steered away from opioids, now dropping any reviews of new meds in the same category — as Nektar recently found out. So maybe they’ll be more open to a new mechanism of action.
Eli Lilly at least has a track record of successfully nabbing approvals based on better safety profiles for their low-dose drugs. The FDA first rejected Olumiant, than OK’d it on the low dose. And the pharma giant is clearly hoping for the same here. But an approval is certainly no guarantee of the big sales once envisioned for this drug. Wolfe’s Tim Anderson shook his head over the last data set, concluding that even if it got by regulators, payers would likely throttle any commercial upside.
Six years ago Eli Lilly paid Pfizer $200 million upfront and promising $1.6 billion in milestones for a shared rights pact on tanezumab. And that was after the FDA forced a pause for the class as they assessed just what kind of threat they were dealing with.
The news on tanezumab arrived with an upbeat assessment of Pfizer’s Q2 numbers. Profits rose 30% with Ibrance, Eliquis and Xeljanz all performing well. Shares are down 1% in early trading Monday.