RALEIGH and DURHAM, N.C., Aug. 19 — Smith & Nephew Biologics & Spine is proceeding to the next stage in the approval process for the U.S. launch of DUROLANE® Single Injection, Stabilized Hyaluronic Acid.
Representatives from the product developer, Q-Med AB of Sweden (“Q-Med”), and their global commercial partner, Smith & Nephew met today with the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee to discuss clinical evidence for the use of DUROLANE® in the treatment of knee pain caused by osteoarthritis (“OA”).
The FDA Advisory Committee did not recommend DUROLANE® for immediate approval, requesting further information as part of the Premarket Approval (“PMA”) process for the product. Smith & Nephew plans to work with Q-Med and the FDA to provide the data required.
Mark Augusti, President of Smith & Nephew Biologics & Spine, said: “We are committed to expanding our range of HA therapies in the United States. Use of our multi-injection SUPARTZ® Joint Fluid Therapy as a treatment for knee OA continues to increase and we are exploring its potential for other indications.”
Q-Med CEO and founder Bengt Agerup 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.”
Ken Reali, SVP and General Manager of Biologics & Spine, added: “Our meeting with the Advisory Committee on single injection DUROLANE® provided some very useful and valuable feedback on our Premarket Approval application. We intend to work with our Q-Med partners and the FDA to initiate the next steps in making this highly successful global product available to U.S. patients.”
Smith & Nephew and Q-Med have an exclusive partnership for the global development and commercialization of DUROLANE®. It is already marketed in 32 countries, including Canada, and has been used to treat the symptoms of OA in more than 350,000 patients worldwide.
Source: Smith & Nephew