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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A new FDA draft guidance is casting a spotlight on a "Holy Grail" in drug development: disease-modifying treatments for osteoarthritis. While most osteoarthritis drugs in the pipeline are intended to treat pain and other symptoms, a handful seek to alter the underlying pathology and structural progression of the disease.

On Aug. 22, the agency issued a two-page guidance for sponsors developing drugs, devices or biological products for these claims. No products have been approved for treatment of structural progression...

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