The FDA on Wednesday published draft guidance to help drug, device and biologic sponsors develop products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA).
The three-page draft features background information on how the agency has relied on patient-reported outcomes in approvals, as well as three bulleted considerations for development.
“Approvals for OA to date have been based on patient-reported outcome measures that assess pain and function. However, treatments that inhibit structural damage or target the underlying pathophysiology associated with OA remain elusive and represent an unmet medical need,” the draft notes.
As far as considerations, FDA says it’s currently unclear “what magnitude of change in structural endpoints would translate to a clinically meaningful benefit to patients (i.e., reliably predict both reduced pain and increased function or prolonged time to end-stage disease). Thus, no structural endpoints have been used for traditional or accelerated approval in OA to date.”
But the ultimate goal, according to the draft, is related to inhibiting structural damage or targeting the underlying pathophysiology associated with OA “to avoid or significantly delay the complications of joint failure and the need for joint replacement, and also to reduce the deterioration of function and worsening of pain.”
FDA also said it welcomes efforts to address considerations, including the ability of treatments to impact common measures of structural progression to reliably predict treatment effects on direct measures of how patients function and feel.
The draft guidance follows the recent positive results for Regeneron Pharmaceuticals and Teva Pharmaceuticals’ Phase III trial for their OA drug fasinumab.
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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