US FDA panel: Let anti-NGF studies move forward, despite 'severe' joint risks
This article was originally published in Scrip
After hearing pleas from patients and experts that the available therapies to treat severe pain are inadequate, advisers to the US FDA said they were not ready to slam the door on an experimental class of drugs, known as anti-nerve growth factors (anti-NGFs), which have been linked to serious adverse effects, including bone and joint deterioration leading to joint-replacement surgery.
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One case of adjudicated arthropathy seen in halted Phase IIb study of anti-NGF candidate. Regeneron still hopes to advance fasinumab, partnered with Teva, into Phase III in osteoarthritis and chronic low back pain – but the second clinical hold for the class puts its future into even greater question.
Regeneron and Teva will partner on the development and commercialization of the late-stage nerve growth factor antibody fasinumab for pain in a deal that will help Regeneron fund a 10,000-patient safety database.
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).