Handful Of Drugs Aim To Modify Osteoarthritis
Disease modifying treatments in Phase II target cartilage repair and regeneration. Sponsors are enthusiastic about FDA guidance offering to help sponsors with their programs.
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US FDA is ‘willing to look at anything’ but sponsors need to demonstrate an effect on pain as drug development challenges remain. Accompanying chart describes 32 drugs in Phase II and Phase III clinical trials and one with a pending biologics license application.
The companies reported positive Phase III data testing the nerve growth factor inhibitor in patients with chronic pain, but the efficacy appears modest and safety will remain a question until long-term Phase III data read out. The companies are focused on a lower 1 mg dose.
Pfizer and Lilly said tanezumab reduced pain in a Phase III osteoarthritis study, but safety is the biggest question for NGF inhibitors. Yet, while Regeneron and Teva discontinued dosing for their fasinumab at its highest dose, tanezumab was effective at both doses in its first Phase III test.