A public meeting to discuss the unmet need for new therapies to treat OA was held on May 16, 2019 in Washington with 80 people attending in person or via webex. The link to the speaker slides is below.
The Pre-Competitive Consortium for OA (PCCOA) was created by OARSI more than a decade ago in response to a Federal Register Notice seeking a critical appraisal on a number of questions that would help to inform the updating of the 1999 guidance for Clinical Development Programs for the Treatment and Prevention OA. Subsequently in 2016, OARSI submitted a White Paper to the FDA providing a comprehensive review and rationale for OA to be defined as a potentially serious disease and to demonstrate that evidence from numerous data analyses provided justification for consideration of the use of surrogate markers in studies of some patients with OA for the early approval of structure modifying drugs. In October of 2018, OARSI responded to another Federal Register Notice seeking comment on a draft guidance for Structural Endpoints for the Development of Products for the Treatment of OA.
With the totality of this work undertaken by OARSI, a public meeting was held on May 16, 2019 in Washington, DC to allow for an open dialog among all meeting participants on the issues surrounding the development of therapies that treat structural progression of OA and the continued unmet medical need for new therapies being available to patients diagnosed with OA.
Click here to see the agenda
Click here to download and view the slides
Background reading - Previous Submissions to FDA Federal Register Notices
Response to Federal Register Notice Critical Appraisal
Appendices_Update to Critical Appraisal 05/2011
PCCOA White Paper
Response to Federal Register Notice Structual Endpoints