FDA Releases Draft Guidance on Arthritis Treatments
The FDA is asking stakeholders to suggest structural endpoints for use in trials of medical products aimed at treating the root cause of osteoarthritis.
Regulators have already approved drugs for treating the pain of osteoarthritis, but no treatments have yet been approved to prevent the underlying structural damage it causes, the agency says in new draft guidance released Wednesday.
The draft guidelines mark the first time the FDA has wrestled with structural endpoints for osteoarthritis in nearly two decades. But it offers few concrete suggestions, instead punting to stakeholders for comment.