J&J, Regeneron follow Pfizer in clinical holds for anti-NGFs
This article was originally published in Scrip
The US FDA last week placed clinical holds on the testing of two separate investigational anti-nerve growth factor (NGF) pain drugs under development by Johnson & Johnson and Regeneron Pharmaceuticals and its partner Sanofi-Aventis after a case of avascular necrosis of a joint was confirmed in a clinical trial participant.
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The partners have filed the first-in-class NGF inhibitor at the lower 2.5mg dose for the treatment of osteoarthritis pain, despite the drug’s challenging safety profile.
Two dosing regimens hit the mark on three co-primary endpoints and the rate of rapidly progressive osteoarthritis was low at 1.3% in a Phase III study of the NGF inhibitor presented on Oct. 23.
Regeneron Pharmaceuticals Inc. reported statistically significant pain relief for osteoarthritis sufferers enrolled in the company's Phase II/III clinical trial for fasinumab, but the data didn't relieve concerns about neuro-musculoskeletal side effects for medicines that inhibit nerve growth factor (NGF).