Q-Med has together with its global partner Smith & Nephew agreed to the next stage in the approval process for the US launch of DurolaneTM Single Injection, Stabilized Hyaluronic Acid.
Representatives from Q-Med AB, Sweden, and Smith & Nephew met August 19th with the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee to discuss clinical evidence for the use of DurolaneTM in the treatment of knee pain caused by osteoarthritis (“OA”).
The FDA Advisory Committee did not recommend DurolaneTM for immediate approval, requesting further information as part of the Premarket Approval (“PMA”) process for the product. Q-Med plans to work with Smith & Nephew and the FDA to provide the data required.
Smith & Nephew and Q-Med have an exclusive relationship for the global development and commercialization of Durolane. It is already marketed in 20 countries, including Canada, and has been used to treat the symptoms of OA in more than 350,000 patients worldwide.
Q-Med’s CEO and founder Bengt Ågerup said, “We are continuing the clinical development of Durolane in collaboration with Smith & Nephew to provide satisfactory clinical evidence of Durolane’s performance. We remain committed to our goal of providing U.S. physicians and patients access to a non-animal single injection product.”