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On August 22, 2018,&nbsp;the U.S.&nbsp;Food and Drug Administration (FDA)&nbsp;published draft guidance to help drug, device and biologic&nbsp;sponsors develop products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA), according to a report by the&nbsp;Regulatory Affairs Professionals Society (RAPS).&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
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 &ndash; <a href="https://t.co/lxhrwwOkGW">https://t.co/lxhrwwOkGW</a>
&mdash; Brian A. Kelly (@BKinSG) <a href="https://twitter.com/BKinSG/status/1032634240993828864?ref_src=twsrc%5Etfw">August 23, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The FDA has recognized that osteoarthritis is a serious disease&nbsp;that has an unmet need, but that there are many factors in treating it,&nbsp;including&nbsp;&ldquo;the multifactorial and complex&nbsp;etiopathogenesis&nbsp;of the disease, the well-recognized discordance between structural&nbsp;changes and signs/symptoms/function, the lack of standard definitions of disease progression, and, correspondingly, the absence of endpoints to reliably assess the ability&nbsp;of a product to alter OA disease progression.&rdquo;&nbsp;In the report, it is stated that the agency replied on patient-reported outcomes for approvals.&nbsp;The report by&nbsp;RAPS&nbsp;said that the FDA&rsquo;s draft states&nbsp;&ldquo;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.&rdquo;&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Osteoarthritis: FDA drafts guidance on developing drugs, devices, biologics &ndash; <a href="https://t.co/CU1uu6p6Hu">https://t.co/CU1uu6p6Hu</a>
&mdash; Engage Tulane (@EngageTulane) <a href="https://twitter.com/EngageTulane/status/1032610143513575426?ref_src=twsrc%5Etfw">August 23, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><a href="https://twitter.com/EIPGeu/status/1032426555429908480">https://twitter.com/EIPGeu/status/1032426555429908480</a>The goal, according to the FDA guideline draft, is to inhibit&nbsp;structural damage or targeting the underlying&nbsp;pathophysiology associated with osteoarthritis,&nbsp;including avoiding joint failure and the worsening of pain.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Fresh on the heels of <a href="https://twitter.com/search?q=%24REGN&amp;src=ctag&amp;ref_src=twsrc%5Etfw">$REGN</a> and <a href="https://twitter.com/search?q=%24TEVA&amp;src=ctag&amp;ref_src=twsrc%5Etfw">$TEVA</a>'s Ph3 success w/OA, FDA puts out a draft guidance, mostly detailing the challenges <a href="https://t.co/57VuXMzkGH">https://t.co/57VuXMzkGH</a>
&mdash; Zach Brennan (@ZacharyBrennan) <a href="https://twitter.com/ZacharyBrennan/status/1032288047893757952?ref_src=twsrc%5Etfw">August 22, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071577.pdf">Click here</a>&nbsp;to read the full OA guideline draft from the FDA.&nbsp;Check out&nbsp;an article on&nbsp;the usage of&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/risankizumab-moderate-plaque-psoriasis/">risankizumab&nbsp;for moderate-to-severe plaque psoriasis</a>.&nbsp;SOURCE:&nbsp;<a href="https://www.raps.org/news-and-articles/news-articles/2018/8/osteoarthritis-fda-drafts-guidance-on-developing">Regulatory Affairs Professionals Society (RAPS)</a>&nbsp;

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FDA Guidance for Osteoarthritis

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 ...

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