Clearing a major roadblock that's keeping Big Pharma from a megablockbuster drug market, a group of FDA experts voted unanimously to allow Pfizer and several other developers to resume testing a new generation of pain medications for osteoarthritis.
The potential benefits of experimental anti-nerve growth factor drugs clearly outweighed the risks associated with the treatments, the panel concluded in a 21 to 0 vote. But now the FDA will be expected to weigh in with its own final decision, adding critical judgments on dosing and drug study designs for anyone looking to re-start testing. Those decisions will have the biggest impact on Pfizer ($PFE), which wants to ramp up a new late-stage study of tanezumab. Regeneron Pharmaceuticals ($REGN), Johnson & Johnson ($JNJ) and AstraZeneca ($AZN)--which voluntarily halted its own work on an anti-NGF treatment drug after the FDA issued a clinical hold for the class--all have their own programs to consider as well. J&J is still studying its pain drug in a group of cancer patients.
Tanezumab had looked like an up-and-coming blockbuster drug in the fall of 2010, when investigators found an alarming need for joint replacement surgeries among patients taking the drug. Now regulators will consider whether Pfizer can go back to the head of the pack with a new Phase III trial adjusted to account for the threat to joints, or start at the beginning with new safety studies.
"There's significant risk but there are probably patient populations where there will be significant benefit," noted Lenore Buckley, professor of internal medicine and pediatrics at Virginia Commonwealth University School of Medicine, according to a report in Bloomberg. Buckley is chairwoman of the FDA advisory panel.
The advisers suggested that Pfizer and its colleagues might want to restrict new trials to those most likely to benefit, while weeding out any patients liable to suffer joint destruction. Any restrictions would likely reduce a potential market once estimated at $11 billion. But even at a reduced level osteoarthritis represents a major market opportunity for the drug developers.