OARSI Requests that FDA Consider Osteoarthritis as a Serious Disease

“Although joint replacement may be extremely effective in the right patients, we believe that earlier therapy with drugs designed to alter the natural history of the disease is warranted and that the innovative development of such therapies should be fostered,” said OARSI President Dr. John Loughlin, PhD. “To meet this goal, we believe that a flexible regulatory environment needs to be developed to allow others to invest development of drugs, that might slow, retard, halt or even form new cartilage, potentially altering the gradual joint destruction often associated with progressive disability.”

The detailed white paper outlines the evidence, demonstrating that OA fulfills the definition of seriousness used in the guidance regarding accelerated approvals by the FDA. The white paper specifically addresses: 

The increasing prevalence of OA along with the risk factors that have been identified in precipitating more patients with OA
The associated morbidity and severity of the disease that leads to increasing disability and limitation of activities of daily living
Newly developed evidence of an increased mortality risk in the US in OA patients; to support this evidence, an individual patient meta-analysis was performed using individual patient raw data from ongoing OA registry cohorts

Based on the data collected, OARSI supports and advocates for the development of new therapies to treat OA. As a regulatory authority, the FDA has a unique role in fostering the development of these therapies, which might alter the natural progression of OA.

For more information on OARSI or to read the white paper in its entirety, visit http://www.OARSI.org.