FDA Guidance for Osteoarthritis

On August 22, 2018, the U.S. Food and Drug Administration (FDA) published draft guidance to help drug, device and biologic sponsors develop products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA), according to a report by the Regulatory Affairs Professionals Society (RAPS). 

This is a significant forward step for imaging biomarkers (among others) in OA. Here is hoping for continued acceleration of therapies OA before well have it!

Osteoarthritis: FDA drafts guidance on developing drugs, devices, biologics – https://t.co/lxhrwwOkGW

— Brian A. Kelly (@BKinSG) August 23, 2018

The FDA has recognized that osteoarthritis is a serious disease that has an unmet need, but that there are many factors in treating it, including “the multifactorial and complex etiopathogenesis of the disease, the well-recognized discordance between structural changes and signs/symptoms/function, the lack of standard definitions of disease progression, and, correspondingly, the absence of endpoints to reliably assess the ability of a product to alter OA disease progression.” 

In the report, it is stated that the agency replied on patient-reported outcomes for approvals. The report by RAPS said that the FDA’s draft states “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.” 

Osteoarthritis: FDA drafts guidance on developing drugs, devices, biologics – https://t.co/CU1uu6p6Hu

— Engage Tulane (@EngageTulane) August 23, 2018

https://twitter.com/EIPGeu/status/1032426555429908480

The goal, according to the FDA guideline draft, is to inhibit structural damage or targeting the underlying pathophysiology associated with osteoarthritis, including avoiding joint failure and the worsening of pain. 

Fresh on the heels of $REGN and $TEVA's Ph3 success w/OA, FDA puts out a draft guidance, mostly detailing the challenges https://t.co/57VuXMzkGH

— Zach Brennan (@ZacharyBrennan) August 22, 2018

Click here to read the full OA guideline draft from the FDA. 

Check out an article on the usage of risankizumab for moderate-to-severe plaque psoriasis. 

SOURCE: Regulatory Affairs Professionals Society (RAPS)